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

This study has been completed.
Sponsor:
Collaborators:
Sahlgrenska University Hospital, Sweden
Sodra Alvsborgs Hospital
Skaraborg Hospital
Uddevalla Hospital
Skane University Hospital
Lund University Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Göteborg University
ClinicalTrials.gov Identifier:
NCT00910975
First received: May 28, 2009
Last updated: September 3, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C, Genotype 1
Drug: Peg-interferon-alfa2a (Pegasys)
Drug: Ribavirin (Copegus)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tailored Treatment of Hepatitis C Genotype 1

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Medication dose per cured patient [ Time Frame: 26 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained virological response and relapse rate [ Time Frame: 26 weeks after end of treatment ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: November 2007
Study Completion Date: September 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Pegasys
Drug: Ribavirin (Copegus)
Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910975

Locations
Sweden
Sahlgrenska University Hospital
Gothenburg, Vastra Gotaland, Sweden, 41346
Sponsors and Collaborators
Göteborg University
Sahlgrenska University Hospital, Sweden
Sodra Alvsborgs Hospital
Skaraborg Hospital
Uddevalla Hospital
Skane University Hospital
Lund University Hospital
Karolinska University Hospital
Investigators
Principal Investigator: Magnus Lindh, MD, PhD Sahlgrenska University Hospital, Sweden
  More Information

Publications:
Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT00910975     History of Changes
Other Study ID Numbers: TTG1_081119
Study First Received: May 28, 2009
Last Updated: September 3, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Göteborg University:
Hepatitis C virus
Real-time PCR
Treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014