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Hepatitis C, Chronic clinical trials

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NCT ID: NCT00727077 Terminated - Hepatitis C Clinical Trials

Post-marketing Surveillance of Children With Chronic Hepatitis C Treated With Intron A (Vial or Pen) and Rebetol (Study P04397)(TERMINATED)

Start date: June 2006
Phase: N/A
Study type: Observational

The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus. This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.

NCT ID: NCT00725842 Terminated - Hepatitis C Clinical Trials

Relapse Rate in Hepatitis C Patients Treated With Peginterferon Alfa-2b Plus Ribavirin in Common Clinical Practice in France (P05484)(Completed)

RE-CHUT
Start date: January 2009
Phase: N/A
Study type: Observational

The objective of this study is to determine the relapse rate in the French patient population with chronic hepatitis C (CHC) previously treated with PegInterferon Alfa-2b (Peg-IFN alfa-2b) plus Ribavirin according to standard clinical practice. Treatment was to be completed prior to the enrollment in the current study. The study will also aim to identify factors that are predictive of relapse. Relapse rate is defined as the percentage of patients with negative viral load at end of treatment who again have positive viral load at 6 months after the end of treatment.

NCT ID: NCT00723879 Terminated - Clinical trials for Hepatitis C, Chronic

Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)

Start date: October 2004
Phase: N/A
Study type: Observational

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which includes (1) medications used for treatment (psychiatric medications); (2) other interventions (nurse support); and (3) educational literature. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.

NCT ID: NCT00705107 Terminated - Hepatitis C Clinical Trials

Adherence to Treatment With PegIntron Pen Plus Rebetol in Treatment-naïve Adult Patients With Hepatitis C in Romania (Study P04247)

Start date: November 2004
Phase: N/A
Study type: Observational

Adherence to the prescribed treatment regimen with PegIntron and Rebetol affects the chance of achieving a sustained virologic response in patients with hepatitis C. The objective of this study is to evaluate the proportion of patients who complete treatment with PegIntron pen and Rebetol while participating in a patient assistance program. The patient assistance program can consist of prophylactic treatment (eg, with growth factors, psychiatric medications) or other interventions (eg, psychotherapy, patient support groups, visiting nurse, nurse telephone calls, educational literature).

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: NCT00662220 Terminated - Chronic Hepatitis C Clinical Trials

High-dose Ribavirin in Treatment of Chronic Hepatitis C Genotype 1 or 4

VIRID
Start date: April 2008
Phase: Phase 3
Study type: Interventional

Optimal ribavirin dosages are essential in achieving SVR (sustained virological response). Several studies have shown higher SVR rates in patients receiving higher doses of ribavirin. Therefore we propose a randomized controlled open label multicenter trial to investigate wether high (25-29mg/kg) dose ribavirin can improve outcome in patients in infected with hepatitis C virus genotype 1 or 4 compared to standard dose (12-15mg/kg).

NCT ID: NCT00641654 Terminated - Chronic Hepatitis C Clinical Trials

Combination Therapy With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 2 or 3 Infection Who Previously Have Relapsed After Therapy With Pegylated Interferon and Ribavirin

RelapC
Start date: January 2007
Phase: Phase 4
Study type: Interventional

To evaluate the efficacy of pegylated interferon alfa-2a 40 kD (PEGASYS) combination therapy with ribavirin (Copegus)given for 24 or 48 weeks in patients with chronic hepatitis C (CHC) virus infection genotype 2 or 3 who responded during (i.e. had HCV-RNA <50 IU/mL at the end of previous therapy), but relapsed after (i.e. had detectable HCV-RNA after the end of prior treatment) previous therapy with pegylated interferon and ribavirin given for at least 12 weeks and at most 24 weeks.

NCT ID: NCT00522808 Terminated - Chronic Hepatitis C Clinical Trials

A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers

CP104
Start date: August 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The purposes of this study are: - to determine the safety and tolerability of multiple doses of A-831 at various doses - to determine how multiple doses of A-831 are distributed through the bloodstream - to determine if A-831 reduces the amount of Hepatitis C virus in the blood