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Hepatitis A clinical trials

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NCT ID: NCT00689390 Terminated - Clinical trials for Hepatitis C, Chronic

Three-year Follow-up of Participants After Administration of Boceprevir or Narlaprevir for the Treatment of Chronic Hepatitis C (P05063)

Start date: February 20, 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Study P05063 is a 3-year long-term follow-up (LTFU) study in participants previously treated with boceprevir (BOC) or narlaprevir (NAR) in a Phase 1, 2, or 3 clinical study. Participants will be followed for up to 3.5 years after the end of their participation in the treatment protocol to document maintenance of the antiviral response (for sustained responders) and to characterize the long-term safety after use of this therapeutic regimen. LTFU procedures include collection of plasma samples for measuring Hepatitis C Virus ribonucleic acid (HCV-RNA) by polymerase chain reaction (PCR) and HCV sequence analysis. No drug therapy will be administered as part of this study.

NCT ID: NCT00687544 Terminated - HIV Infections Clinical Trials

Efficacy and Safety of PegIntron Plus Ribavirin for Treatment of Chronic Hepatitis C in HIV-Infected Subjects (Study P04469)(TERMINATED)

Start date: December 2005
Phase: Phase 4
Study type: Interventional

In this study, adult Indonesian subjects with human immunodeficiency virus (HIV) coinfected with chronic hepatitis C (CHC) will be given peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) combination therapy. The efficacy rate (sustained virologic response, end of treatment virologic response, and sustained biochemical response), the subject morbidity rate as caused by other opportunistic infection (eg, bacterial pneumonia, tuberculosis, and other bacterial infection), and the safety and tolerability of this combination therapy will be examined.

NCT ID: NCT00686881 Terminated - Clinical trials for Hepatitis C, Chronic

Efficacy of Peginterferon Alfa-2b (SCH 054031) vs Glycyrrhizin in Interferon (IFN)-Treated Patients With Chronic Hepatitis C and F2/F3 Liver Fibrosis (P04773)

Start date: December 2006
Phase: Phase 3
Study type: Interventional

The objective of this study is to compare the efficacy of peginterferon alfa-2b (PegIFN-2b) monotherapy administered at a dose of 0.5 ug/kg vs stronger neo minophagen C (SNMC) in participants with chronic hepatitis C (CHC) and liver fibrosis (Metavir fibrosis score of F2 and F3) who were previously treated with interferon. The trial will evaluate the effect of treatment on the progression of liver fibrosis, liver inflammation, and liver function. Treatment will be administered for up to 156 weeks with a 4-week follow-up.

NCT ID: NCT00686790 Completed - Clinical trials for Hepatitis B, Chronic

Efficacy of Peginterferon Alfa-2b in Previously Untreated Subjects With Chronic Hepatitis B and D Co-infection (Study P04603)

Start date: December 2005
Phase: Phase 3
Study type: Interventional

The objective of this study is to determine the effectiveness of peginterferon alfa-2b 1.5 mcg/kg/week administered for 52 weeks (wk) in previously untreated participants coinfected with hepatitis virus B and D. After 52-week treatment and 52-week follow-up, the virologic, biochemical, and histological response will be evaluated.

NCT ID: NCT00686777 Completed - Clinical trials for Hepatitis C, Chronic

Pegylated Interferon (PEG-IFN) Alfa-2b and Low Dose Ribavirin for the Treatment of Chronic Hepatitis C Patients With Genotype 1 High Viral Load and Low Body Weight (Study P05172)(COMPLETED)

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The objective is to evaluate the efficacy and safety of the combination therapy with subcutaneous (SC) Pegylated Interferon (PEG-IFN) alfa-2b 1.5 ug/kg/week plus low-dose ribavirin administered for 48 weeks in participants with chronic hepatitis C virus (HCV) who are infected with HCV genotype 1 high viral load, and weigh 50 kg or less.

NCT ID: NCT00686517 Completed - Hepatitis C Clinical Trials

Evaluation of Peginterferon Alfa-2b Monotherapy and Combination With Ribavirin in Participants With Acute Hepatitis C (P03552/MK-4031-137)

Start date: December 2003
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

NCT ID: NCT00684671 Completed - Hepatitis B Clinical Trials

Evaluation of Immune Memory to Twinrix or Comparator by Challenge Dose Administration 4 Years After Primary Vaccination

Start date: May 26, 2008
Phase: Phase 4
Study type: Interventional

Only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.

NCT ID: NCT00684268 Completed - Hepatitis C Clinical Trials

Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders

NRSily
Start date: October 2007
Phase: Phase 2
Study type: Interventional

By chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis C virus. Based on the results of the dose finding study (published) te optima dosing schedule is explored.This study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis C).

NCT ID: NCT00682591 Withdrawn - Clinical trials for Chronic Hepatitis C Infection

Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy

Start date: July 2008
Phase: N/A
Study type: Observational

Prospective, longitudinal multi-center study performed in 15 participating substitution centers in Germany. Aims: - Primary objective: To compare the impact of the different substitution drugs (methadone, buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related tolerability in opioid dependent patients under HCV treatment. - Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e.g. retention rates, concomitant drug use and in particular neurocognitive function) and tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone

NCT ID: NCT00680342 Completed - Chronic Hepatitis C Clinical Trials

Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment

SyNCH
Start date: April 2008
Phase: Phase 2
Study type: Interventional

Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to have liver protecting effects; however, this benefit has not been proven. The purpose of this research study is to determine the effectiveness of silymarin and assess the safety of different silymarin doses in patients with varying severity of liver disease compared to a placebo (lactose pill). Eligible subjects will be randomized to treatment with placebo or one of two dosages of Legalon® 420 mg or 700 mg administered orally thrice daily. Investigators and subjects will be masked to treatment assignment. The study design includes a screening period during which patients will undergo full medical evaluation to verify protocol eligibility and a treatment period of 24 weeks during which time clinic visits and laboratory studies will be performed every 2-4 weeks to monitor for safety and efficacy of therapy. Subjects will continue to be followed for an additional 12 weeks after the completion of study medication to monitor for adverse events and investigate post-treatment outcomes. Participation in this research study requires the subject to travel to the clinic for at least 10 visits so recruitment will be limited to a geographically restricted area around participating clinical centers.