In Clinical Trials Sample Clauses

In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before), did not have cirrhosis and were treated with Harvoni® for 12 weeks had a 99% response (cure) rate. Those who had a baseline viral load of less than 6 million and were treated for 8 weeks had a 97% response rate. Persons with cirrhosis who were treatment-naïve had a 94% response rate. Persons without cirrhosis in whom prior treatment failed and were treated for 12 weeks had a 95% response rate. Persons with cirrhosis in whom prior treatment failed and were treated for 24 weeks had a 100% response rate.
Sample 1
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In Clinical Trials. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin had a 95% response rate. Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). For those with genotypes 5 and 6, sofosbuvir in combination with peginterferon and ribavirin for 12 weeks is an alternative treatment. In one clinical trial all 6 subjects with genotype 6 and the 1 subject with genotype 5 responded to treatment.
Sample 1
In Clinical Trials. The overall treatment response (cure) rate for Epclusa® and ribavirin given for 12 weeks was 94% for persons with hepatitis C genotypes 1, 2, 3, and 4 with decompensated cirrhosis (Child- Xxxx B or C) who were never treated before or were treated in the past with peginterferon and ribavirin with or without a protease inhibitor (ASTRAL-4). Persons with genotype 1a had a 94% (51/54) response rate. Those with genotype 1b had a 100% (14/14) response rate. Persons with genotype 2 had a 100% (4/4) response rate. Those with genotype 3 had an 85% (11/13) response rate. Persons with genotype 4 had a 100% (2/2) response rate. Genotype 3 subjects with pretreatment Y93H resistance associated polymorphisms (RAPs) treated for 12 weeks with Epclusa® had an 80% response rate. Those with compensated cirrhosis and pretreatment RAPs had a 67% response rate. It is expected that the sustained virologic response rate will improve with the addition of ribavirin.
Sample 1
In Clinical Trials. The treatment response (cure) rate for Epclusa® given for 12 weeks was 99% overall for persons with genotypes 1, 2, 4, 5, and 6 who were never treated before or were treated in the past with peginterferon and ribavirin with or without a protease inhibitor, who did not have cirrhosis, or had compensated (mild) cirrhosis (ASTRAL-1). Persons with genotype 1a had a 98% response rate (ASTRAL -1). Persons with genotype 1b had a 99% response rate (ASTRAL -1). Persons with genotype 2 had a 99% response rate (ASTRAL-2). Persons who were genotype 4 had a 100% response rate (ASTRAL -1). Persons with genotype 5 had a 97% response rate (ASTRAL -1). Persons with genotype 6 had a 100% response rate (ASTRAL -1). The treatment response rate for Epclusa® given for 12 weeks was 95% overall for persons with genotype 3 (ASTRAL-3). For persons with genotype 3 who were treatment naïve without cirrhosis, the response rate was 98% (ASTRAL -3). Persons with genotype 3 who were treatment experienced without cirrhosis had a response rate of 94% (ASTRAL -3). Persons with genotype 3 who were treatment naïve (never before treated) and had compensated (mild) cirrhosis had a 93% response rate (ASTRAL -3). Persons with genotype 3 who were treatment experienced with compensated (mild) cirrhosis had an 89% response rate (ASTRAL -3).
Sample 1
In Clinical Trials. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin had a 97% response rate (39 patients studied). Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). Few data from clinical trials are available for genotypes 5 and 6. Therefore if persons with genotype 5 or 6 need immediate treatment, daily sofosbuvir in combination with peginterferon and ribavirin therapy for 12 weeks is recommended by the AASLD and IDSA. No data supports use of a peginterferon-free treatment regimen for those with genotype 5 or 6.
Sample 1
In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before), did not have cirrhosis, and were treated with Harvoni® for 12 weeks had a 99% response (cure) rate. In persons with a baseline viral load of less than 6 million who did not have cirrhosis, the response rate was 97% with 8-week treatment and 96% with 12-week treatment. Persons with cirrhosis who were treatment-naïve had a 94% response rate. Persons without cirrhosis in whom prior treatment with peginterferon, ribavirin and/or a protease inhibitor failed were treated for 12 and 24 weeks with Harvoni®. The response in those who took 12 weeks was 95% and for those who received 24 weeks the response was 99%. Persons with cirrhosis in whom prior treatment with peginterferon, ribavirin, and/or a protease inhibitor failed had an 86% response to 12 weeks and 100% response rate to 24 weeks of Harvoni®. There are no data available on the use of Harvoni for 24 weeks in decompensated cirrhosis. However, in one study of this regimen in persons with genotype 1 with compensated cirrhosis the response was 71%. Persons with genotypes 4, 5, or 6 regardless of prior treatment experience or the presence or absence of compensated cirrhosis took Harvoni® for 12 weeks. Persons who were genotype 4 or 5 had a 93% or better treatment response (cure) rate. Those who were genotype 6 had a 96% response rate.
Sample 1
In Clinical Trials. Persons with genotype 1 who were treatment-naïve (never treated before) and did not have cirrhosis and were treated with sofosbuvir in combination with peginterferon and ribavirin for 12 weeks had a 90% response (cure) rate. Persons who were treatment-naïve genotype 1 with cirrhosis, had an 80% response rate. Those with multiple factors that affect treatment (advanced fibrosis, IL-28b CT or TT genotype (see explanation of test page 2), virus > 800,000 IU/ml) had a 71% response rate. Those who failed previous peginterferon/ribavirin therapy are expected to have approximately this same rate of cure (71%) based on computer modeling. Persons with genotype 1 who were treatment-naïve and were given sofosbuvir plus ribavirin (no peginterferon) for up to 24 weeks had response rates from 50-84% in clinical trials with an overall response rate of 72%. Persons with genotype 2 who were treatment naïve had a ≥ 95% chance of achieving a sustained virologic response from sofosbuvir and ribavirin for 12 weeks. Those with cirrhosis had a response rate of 83% in clinical trials. Persons with genotype 3 who were treatment-naïve, regardless of cirrhosis status had a ≥ 92% response rate to sofosbuvir in combination with ribavirin for 24 weeks. For those who were treatment-experienced, the response rate was 77% and treatment-experienced with cirrhosis, the response rate was 60%. Persons with genotype 3 who were treatment-naïve and were given sofosbuvir in combination with peginterferon and ribavirin (4 to 12 weeks) had a 97% response rate (39 patients studied). Persons with genotype 4 who were treatment-naïve had a 96% response rate to sofosbuvir in combination with peginterferon and ribavirin for 12 weeks. Note, the number of genotype 4 patients in clinical trials was small (28 patients studied). Few data from clinical trials are available for genotypes 5 and 6. Therefore if patients with genotype 5 or 6 need immediate treatment, daily sofosbuvir in combination with peginterferon and ribavirin therapy for 12 weeks is recommended by the American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA). No data supports use of a peginterferon-free treatment regimen for those with genotype 5 or 6.
Sample 1
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Related to In Clinical Trials

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Trials The Ship shall run the following test and trials: (1) Harbour Acceptance Tests, including setting to work of the various equipment;

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Commercialization Plan (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods. (b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch. (c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].

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