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Hepatitis A 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: NCT00725751 Completed - Clinical trials for Hepatitis C, Chronic

Treatment of Chronic Hepatitis C With Pegylated Interferon and Ribavirin in Participants With/Without Substitution Therapy (P05255)

Start date: September 2007
Phase: N/A
Study type: Observational

Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).

NCT ID: NCT00725205 Completed - Hepatitis C Clinical Trials

Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)

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

Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.

NCT ID: NCT00724893 Completed - Hepatitis C Clinical Trials

Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)

Start date: August 2005
Phase: N/A
Study type: Observational

Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.

NCT ID: NCT00724854 Completed - Hepatitis C Clinical Trials

Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)

APEGIN
Start date: August 2006
Phase: N/A
Study type: Observational

The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).

NCT ID: NCT00724776 Completed - Chronic Hepatitis C Clinical Trials

Albinterferon Alfa 2b Single Dose in Japanese Chronic Hepatitis C Patients

Start date: July 2008
Phase: Phase 1
Study type: Interventional

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients

NCT ID: NCT00724620 Completed - Clinical trials for Hepatitis C, Chronic

PEG-IFN Alfa-2b Plus Ribavirin for Treatment of Mexican naïve Patients With Chronic Hepatitis C Infected With Genotype 1 (Study P04511)(COMPLETED)

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

This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1 patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks. At the end of this period, quantitative PCR will be used to determine the Early Viral Response (EVR) at this point of treatment. Total treatment duration will be 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.

NCT ID: NCT00724464 Completed - Hepatitis C Clinical Trials

Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)

Start date: December 2007
Phase: N/A
Study type: Observational

The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.

NCT ID: NCT00724451 Completed - Hepatitis C Clinical Trials

Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)

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

The goal of this study is to elucidate the reasons why patients with chronic hepatitis C (CHC) would not be considered eligible for antiviral treatment. The study is conducted in common clinical practice at approximately 54 sites in Italy. Patients deemed eligible for antiviral therapy will be treated at the discretion of the physician with either peginterferon alfa-2a or peginterferon alfa-2b, both in combination with ribavirin, in accordance with approved labeling. A secondary objective of this study is to define "treatment failure" and to evaluate the reasons for treatment discontinuation.