Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C (TTG1)

September 3, 2012 updated by: Göteborg University

Tailored Treatment of Hepatitis C Genotype 1

The purpose of the study is to investigate if the duration of treatment of hepatitis C with pegylated interferon and ribavirin can be individualized on the basis of how fast the hepatitis C virus concentration in the blood decreases, and if this is more cost-efficient than standard treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The current standard regimen for patients with chronic hepatitis C virus (HCV) infection, i.e., 48 weeks of pegylated interferon and ribavirin, needs to be further improved because of high costs and side-effects; in addition, the treatment is curative in only 50% of patients with genotype 1 of HCV. According to the current guidelines treatment with pegylated interferon and ribavirin is given for 24, 48 or 72 weeks depending on the time point when HCV-RNA becomes undetectable (week 4, 12 or 24). Patients with a very poor response may also be identified by applying a stopping rule at week 12 and 24. Still, most patients are treated for 48 weeks and a substantial number of those relapse after discontinuation.

In this study, standard treatment is compared with "tailored treatment", when the treatment duration is based on the time point when HCV RNA level is calculated to be 1 copy/mL, according measurements of HCV RNA on day 14, 21, 28 and 49. This arm also includes an earlier stopping rule: If the HCV RNA does not decline significantly between day 14 and 28, treatment is stopped after 5 weeks.

The advantage of tailored treatment is hypothesised to be that unnecessary side-effects and costs are avoided by an earlier identification of non-response and a treatment duration that is optimised for each patient.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Vastra Gotaland
      • Gothenburg, Vastra Gotaland, Sweden, 41346
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Anti-HCV positive for > 6 months
  • Genotype 1
  • Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
  • Negative pregnancy test (for fertile women)

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Antiviral or immune modulating treatment the last 6 months
  • Hepatitis B or HIV infection (HBsAg, anti-HIV)
  • Other significant chronic liver disease
  • History of bleeding esophageal varices or other signs of decompensation
  • Neutrophiles < 1.0 x 109/L or platelets < 50 x 109/L. S-creatinine > 2 x ULN
  • History of severe psychiatric disorder
  • Autoimmune disease, severe heart disease, previous organ or stem cell transplantation, malignancy, thyroid disease, severe retinopathy
  • Drug abuse, current or during the last year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment is given for 24, 48 or 72 weeks depending on the time point (week 4, 12 or 24) when HCV RNA becomes undetectable by the Cobas Taqman assay. If HCV RNA has not declined 2 logs by week 12 or is detectable at week 24, treatment is stopped.
Drug: Peg-interferon-alfa2a (Pegasys)
Peg-interferon-alfa2a 180 µg per week
Other Names:
  • Pegasys
Drug: Ribavirin (Copegus)
Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg
Experimental: Tailored treatment
Treatment with Pegasys 180 µg/week and ribavirin 1000/1200 mg per day. Treatment duration is flexible, 24-72 weeks, depending on the time point when the HCV RNA level is calculated to be 1 copy/mL. If the decline between day 14 and 28 is poor, treatment is stopped after 5 weeks.
Drug: Peg-interferon-alfa2a (Pegasys)
Peg-interferon-alfa2a 180 µg per week
Other Names:
  • Pegasys
Drug: Ribavirin (Copegus)
Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication dose per cured patient
Time Frame: 26 weeks after end of treatment
26 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response and relapse rate
Time Frame: 26 weeks after end of treatment
26 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Skane University Hospital
Lund University Hospital
Skaraborg Hospital
Uddevalla Hospital
Sodra Alvsborgs Hospital

Investigators

  • Principal Investigator: Magnus Lindh, MD, PhD, Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

June 1, 2009

Study Record Updates

Last Update Posted (Estimate)

September 5, 2012

Last Update Submitted That Met QC Criteria

September 3, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TTG1_081119

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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