Monday, May 13, 2013

Hepatitis C Clinical Trials - Updates For May/April 2013

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Today In The News
U.S. FDA grants priority review to Simeprevir (TMC435) for combination treatment of genotype 1 chronic hepatitis C
Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered as a 150 mg capsule once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease.... 

Not yet recruiting
A Study of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin in Participants With Chronic HCV Infection
Conditions: Hepatitis C, Chronic; Infection
Interventions: Drug: TMC435; Drug: Pegylated interferon alfa-2a (PegIFNα-2a); Drug: Ribavirin (RBV)

In The News
Hepatitis C care "at risk" in the UK, say Roche

From NATAP

Roche started in the Spring 2012 a 3 & drug IFN-free regimen study, results expected to be presented soon
3 & 4 Oral IFN-Free Roche HCV Regimens Studies, Treatment Naïve or Null Responders: setrobuvir+mericitabine+danoprevir/r+rbv. ANNAPURNA Study
http://www.natap.org/2012/HCV/090412_01.htm

Of Interest
In Brazil, Mexico and Argentina, Dual Combination Therapy With Peg-IFN-alpha and Ribavirin Remains the Most Commonly Prescribed Treatment for all Hepatitis C Virus-Infected Patients

However, Recent Changes in Brazil and Argentina are Expected to Drive a Shift in Treatment of HCV Genotype 1 Infections, According to a New Report From Decision Resources

"Initiatives to include protease inhibitors in public programs in all three countries are currently gaining momentum," said Decision Resources Analyst Andreia Ribeiro, Ph.D. "In Brazil, Incivo and Victrelis are now being incorporated in public reference hospitals and state HCV programs, after a positive recommendation by CONITEC (the national HTA body) for the inclusion of protease inhibitors in the National Health System in July, 2012. In Argentina, the Superintendencia de Servicios de Salud recently included protease inhibitors in the coverage of the Single Refund System. Therefore, the different SS funds (Obras Sociales) can now be reimbursed for the provision of triple therapy treatment to HCV1 patients. Additionally, in Mexico, the fact that Victrelis was recently included in the national formularies may lead to the incorporation of this drug in the SS sector soon."...

Hepatitis Clinical Trials Listed @ Clinical Trials.gov
View all Trial Updates @ ClinicalTrials.gov: last 30 days

In The News
Gilead Sofosbuvir and ledipasvir: Plans to initiate a third Phase 3 clinical trial with and without ribavirin
May. 2, 2013-- Gilead Sciences (Nasdaq: GILD) today announced plans to initiate a third Phase 3 clinical trial of the company’s investigational fixed-dose combination tablet of sofosbuvir and ledipasvir for the treatment of chronic hepatitis C virus (HCV) infection. The study, called ION-3, will evaluate the once-daily fixed-dose combination of sofosbuvir and ledipasvir for eight weeks with and without ribavirin (RBV) and for 12 weeks without RBV in 600 non-cirrhotic, treatment-naïve genotype 1 HCV-infected patients.

Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
‎Friday, ‎May ‎03, ‎2013, ‏‎12:00:00 PM
Condition: Chronic Hepatitis C Virus
Interventions: Drug: Sofosbuvir/Ledipasvir 400/90 mg; Drug: Ribavirin
Sponsors: Gilead Sciences; Gilead Sciences
Recruiting - verified May 2013

A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
‎Wednesday, ‎April ‎24, ‎2013, ‏‎12:00:00 PM
Conditions: Chronic Hepatitis C; CHC; HCV; Hepatitis C
Interventions: Drug: VX-135; Drug: Daclatasvir
Sponsors: Vertex Pharmaceuticals Incorporated; Vertex Pharmaceuticals Incorporated
Not yet recruiting - verified April 2013

In The News
Achillion Initiates Phase 2 Interferon-Free Trial of Sovaprevir and ACH-3102 for Genotype 1 HCV
April 16, 2013 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc today announced that it has initiated an international Phase 2 clinical trial with sovaprevir and ACH-3102 for the treatment of genotype 1 chronic hepatitis C (HCV). The trial will evaluate an all-oral 12-week interferon-free regimen consisting of sovaprevir, ACH-3102, and ribavirin in patients with chronic HCV who have not received prior therapy..

Safety, Tolerability and Efficacy of 12-weeks of Sovaprevir, ACH-3102 and Ribavirin in Treatment-naive GT-1 HCV Subjects
‎Thursday, ‎April ‎18, ‎2013, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Interventions: Drug: sovaprevir; Drug: ACH-3102; Drug: Ribavirin; Drug: Placebo
Sponsors: Achillion Pharmaceuticals; Achillion Pharmaceuticals
Recruiting - verified May 2013

Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection.
‎Monday, ‎April ‎15, ‎2013, ‏‎12:00:00 PM
Condition: Hepatitis C Virus
Interventions: Drug: Sofosbuvir; Drug: Ribavirin (RBV)
Sponsors: Gilead Sciences; Gilead Sciences
Recruiting - verified April 2013

View all updates here...

Hepatitis Clinical Trials Listed @ CenterWatch

A listing of Hepatitis medical research trials actively recruiting patient volunteers. Click on the state  to find more detailed information on a research study in your area.

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