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TERMINATEDPHASE4

Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients

Optimization of Treatment for Patients With Chronic Hepatitis C Infected With HCV-genotype 2 or 3: 12 vs. 24 Weeks of Treatment Extension for Patients Without Rapid Virological Response

NCT00803309•HepNet Study House, German Liverfoundation

View on ClinicalTrials.gov

Summary

In this study we intend to treat patients with chronic hepatitis C of genotype 2 or 3 having characteristics associated with poor treatment response for additional 12 or 24 weeks beyond the standard treatment of PEG-IFN alpha-2b plus ribavirin. The objective of this study is to compare the efficacy of a treatment extension of 12 versus 24 weeks in patients with HCV-genotypes 2 and 3 who are treated with 1.5 µg/kg PEG-IFN alpha-2b and 800-1400 mg ribavirin (standard dose) for 24 weeks (standard duration) and who are not HCV-RNA negative (\< 15 IU/ml) after 4 weeks of standard treatment but HCV-RNA negative after 16-24 weeks of standard treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients with HCV-genotype 2/3 chronic hepatitis C documented by detectable plasma HCV RNA (\> 15 IU/mL) and positivity of anti-HCV antibodies
•Age ≥ 18 years
•Compensated liver disease (Child-Pugh Grade A clinical classification)
•Negative urine or blood pregnancy test (one of the both; for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. Additionally, all fertile males and females must be using two forms of effective contraception during treatment and during the 7 months after treatment end. This includes using birth control pills (no interaction with investigational drugs), IUDs, condoms, diaphragms, or implants, being surgically sterilized, or being in a post-menopausal state. At least one contraception method must be of barrier method
•Ongoing treatment with 1.5 µg/kg Peg-Interferon alpha-2b (PegIntron®) and \> 10.6 mg/kg ribavirin (Rebetol®)
•No rapid virological response (HCV-RNA positive after week 4 of the ongoing therapy)
•Willingness to give written informed consent and willingness to participate to and to comply with the study protocol

Exclusion Criteria

•Women with ongoing pregnancy or breast feeding
•Male partners of women who are pregnant
•Positive tests at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, HBeAg, anti-HIV, HIV-RNA
•History or other evidence of a medical condition associated with chronic liver disease other than HCV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
•History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
•Patients with liver cirrhosis with a lesion suspicious for hepatic malignancy on the screening
•Absolute neutrophil count (ANC) \<750 cells/mm3 at screening
•Platelet count \<50,000 cells/mm3 at screening
•Hb \<10 g/dl at screening
•Dose modification of Peg-Interferon alpha-2b (PegIntron®) or ribavirin (Rebetol®) during the first 4 weeks of the ongoing therapy
+18 more criteria

Locations (49)

Ärztehaus Leipziger Straße

Berlin, Germany

Medizinisches Infektiologiezentrum

Berlin, Germany

Praxis Dr. med. Naumann

Berlin, Germany

Hepatologische Schwerpunktpraxis im bng

Berlin, Germany

Charité Campus Virchow-Klinikum, Med. Klinik für Gastroenterologie und Hepatologie

Berlin, Germany

Praxis Dr. med. J. Gölz

Berlin, Germany

Praxis Meyer

Berlin, Germany

Friedrich-Wilhelms-Universität, Med. Klinik und Poliklinik I

Bonn, Germany

Klinikum Bremen-Mitte gGmbH

Bremen, Germany

Kreiskliniken Burghausen/Altötting, Med. Klinik II

Burghausen/Altötting, Germany

Key Dates

Start Date

November 1, 2008

Primary Completion Date

August 1, 2013

Completion Date

August 1, 2013

Last Updated

August 28, 2017

Enrollment

ACTUAL participants

Conditions

Hepatitis C, Chronic

Interventions

pegylated interferon alpha-2b

DRUG

Ribavirin

DRUG

pegylated Interferon alpha-2b

DRUG

Ribavirin

DRUG

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

NCT05870969

Carcinoma, HepatocellularHepatitis C, Chronic+3 more

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COMPLETEDPHASE4

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

NCT03987503

Hepatitis C, Chronic

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Assess the Efficacy of 12 Versus 24 Weeks of Extended Treatment in HCV-Genotype 2/3 Patients

Inclusion Criteria

Exclusion Criteria

Digitalized Surveillance Management for Liver Cancer Risk Population in Improving Eearly Diagnosis Efficancy in Chinese Population (dSEARCH)

The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Safety And Efficacy Of Oral PF-4136309 In Patients With Chronic Hepatitis C Infection And Abnormal Liver Enzymes

Addition of ISIS 14803 to Therapy With Peginterferon and Ribavirin for Chronic Hepatitis C (HCV) Patients Not Responding Adequately to the Two Drugs

The Pharmacokinetics of P1101 + Ribavirin in Interferon Treatment-Naïve Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection