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Articles Of Interest
COMMENTARY ON: Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C.
Both Simeprevir and Sofosbuvir Likely Approved by 2014-Clinical/Ethical/Pharmacoeconomic Dilemmas Loom
Sofosbuvir -FDA Grants Priority Review, Approval Set For December
Hepatitis C Therapy Update 2013-What About Interferon-free Regimens?
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Sofosbuvir Trial Updates For July 2013
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Phase 3 Study of Sofosbuvir and Ribavirin
This study is currently recruiting participants
Purpose
Sofosbuvir and ribavirin in Japanese subjects with chronic Hepatitis C.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01910636 History of Changes |
| Other Study ID Numbers: | GS-US-334-0118 |
| Study First Received: | July 23, 2013 |
| Last Updated: | July 25, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
| ____________________________________________________ Phase 2 Study of SOF+GS-5816 in Treatment Experienced Subjects With Chronic Genotype 3 HCV This study is currently recruiting participants Purpose This study will evaluate sofosbuvir (SOF)+GS-5816 for the treatment of chronic genotype 3 Hepatitis C Virus (HCV) infection in treatment experienced subjects.
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This study is currently recruiting participants
Purpose
Open label study of GS-7977 in combination with ribavirin (RBV) with or without Peginterferon Alfa-2a (PEG) in adults with chronic HCV who participated in a prior Gilead HCV study and have not achieved SVR.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01625338 History of Changes |
| Other Study ID Numbers: | GS-US-334-0109 |
| Study First Received: | June 7, 2012 |
| Last Updated: | June 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
This study is currently recruiting participants
Purpose
This is a research study to evaluate the safety, tolerability, and anti-viral activity of sofosbuvir with ribavirin in Egyptian adults with genotype 4 hepatitis C infection
Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Open-Label, Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naïve and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection. |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01838590 History of Changes |
| Other Study ID Numbers: | GS-US-334-0138 |
| Study First Received: | April 15, 2013 |
| Last Updated: | May 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
A Phase 2a Study of GS-6624 in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis
This study is currently recruiting participants.
Purpose
This is an open label, exploratory study of GS-6624 in adult subjects infected with HIV, HCV, or co-HIV/HCV with histological evidence of liver fibrosis. Subjects will receive 700 mg IV GS-6624 every 2 weeks for a total of 24 weeks (12 infusions) while continuing on standard therapy for HIV (HIV-infected subjects only).
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2a Study of an Anti-LOXL2 Monoclonal Antibody (GS-6624) in HIV and/or Hepatitis C- Infected Subjects With Liver Fibrosis |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01707472 History of Changes |
| Other Study ID Numbers: | GS-US-321-0107 |
| Study First Received: | September 11, 2012 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
This study is currently recruiting participants.
Purpose
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01817985 History of Changes |
| Other Study ID Numbers: | GS-US-281-0112 |
| Study First Received: | March 20, 2013 |
| Last Updated: | July 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
This study is currently recruiting participants.
Purpose
This is an Open-label Phase 3 study in subjects with chronic Genotype 1, 2, 3, and 4 HCV-infection who are co-infected with HIV-1. A total of 220 HCV subjects who are co-infected with HIV-1 will be enrolled into a single arm and treated with oral SOF 400 mg QD plus weight based RBV (1000 or 1200 mg/day) BID for 12 weeks or 24 weeks. The study population will include HCV genotype 1, 2, 3, and 4 HCV treatment naive subjects (including IFN ineligible) and HCV genotype 2 and 3 HCV treatment experienced subjects who have failed prior therapy with PEG/RBV. Approximately 20% of the subjects enrolled will have evidence of compensated cirrhosis at Screening.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01783678 History of Changes |
| Other Study ID Numbers: | GS-US-334-0124 |
| Study First Received: | January 31, 2013 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection.
This study is currently recruiting participants.
Purpose
The purpose of this study is to determine the effectiveness and safety of sofosbuvir plus ribavirin administered for 16 weeks and 24 weeks in patients with chronic genotype 1 or 3 HCV infection
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3b, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection. |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01896193 History of Changes |
| Other Study ID Numbers: | GS-US-334-0119 |
| Study First Received: | July 2, 2013 |
| Last Updated: | July 8, 2013 |
| Health Authority: | Russia: Ministry of Health of the Russian Federation |
Phase 2 Study of SOF+GS-5816 in Treatment Naive Subjects With Chronic HCV
This study is ongoing, but not recruiting participants.
Purpose
This study will evaluate sofosbuvir (SOF)+GS-5816 for the treatment of Hepatitis C Virus (HCV) infection.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Sofosbuvir+ GS-5816 for 12 Weeks in Treatment-naive Subjects With Chronic HCV Infection |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01858766 History of Changes |
| Other Study ID Numbers: | GS-US-342-0102 |
| Study First Received: | May 10, 2013 |
| Last Updated: | July 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)
This study is ongoing, but not recruiting participants.
Purpose
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of Sofosbuvir/Ledipasvir (FDC) with or without RBV administered for 8 weeks and Sofosbuvir/Ledipasvir (FDC) administered for 12 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) +/- Ribavirin for 8 Weeks and Sofosbuvir/Ledipasvir Fixed-Dose Combination (FDC) for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01851330 History of Changes |
| Other Study ID Numbers: | GS-US-337-0108 |
| Study First Received: | May 3, 2013 |
| Last Updated: | July 19, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Subjects With Chronic Genotype 1, 2, or 3 HCV Infection
This study is currently recruiting participants.
Purpose
The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of combination therapy with sofosbuvir (SOF)-containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01826981 History of Changes |
| Other Study ID Numbers: | GS-US-337-0122 |
| Study First Received: | April 1, 2013 |
| Last Updated: | April 4, 2013 |
| Health Authority: | New Zealand: Medsafe |
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Expanded Access Program of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon in Aggressive Post-transplant Hepatitis C
Expanded access is currently available for this treatment.
Purpose
This is a single arm, open-label study which will be opened at specific clinical sites at the request of an investigator for the treatment of individual subjects for whom there are no other treatment options. Subjects will be treated for 24 weeks with sofosbuvir (400mg QD) with RBV; pegylated interferon may be added at the discretion of the investigator.
| Study Type: | Expanded Access What is Expanded Access? |
| Official Title: | An Expanded Access Phase 2 Study of Sofosbuvir With Ribavirin and With or Without Pegylated Interferon for 24 Weeks in Subjects Who Have Undergone Liver Transplantation and Who Have Aggressive, Recurrent Hepatitis C Infection |
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01779518 History of Changes |
| Other Study ID Numbers: | GS-US-334-0139 |
| Study First Received: | January 23, 2013 |
| Last Updated: | June 14, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
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