Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C
NCT ID: NCT00910975
Last Updated: 2012-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2007-11-30
2011-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Peg-interferon-alfa2a (Pegasys)
Peg-interferon-alfa2a 180 µg per week
Ribavirin (Copegus)
Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg
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.
Peg-interferon-alfa2a (Pegasys)
Peg-interferon-alfa2a 180 µg per week
Ribavirin (Copegus)
Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg
Interventions
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Peg-interferon-alfa2a (Pegasys)
Peg-interferon-alfa2a 180 µg per week
Ribavirin (Copegus)
Ribavirin 1000 or 1200 mg per day depending on if body weight is below or above 75 kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Genotype 1
* Clinical indication for treatment, preferably a liver biopsy showing significant inflammation and/or fibrosis
* Negative pregnancy test (for fertile women)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Sodra Alvsborgs Hospital
OTHER
Skaraborg Hospital
OTHER_GOV
Uddevalla Hospital
UNKNOWN
Skane University Hospital
OTHER
Lund University Hospital
OTHER
Karolinska University Hospital
OTHER
Göteborg University
OTHER
Responsible Party
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Principal Investigators
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Magnus Lindh, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, Västra Götaland County, Sweden
Countries
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References
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Lindh M, Alestig E, Arnholm B, Eilard A, Hellstrand K, Lagging M, Wahlberg T, Wejstal R, Westin J, Norkrans G. Response prediction and treatment tailoring for chronic hepatitis C virus genotype 1 infection. J Clin Microbiol. 2007 Aug;45(8):2439-45. doi: 10.1128/JCM.00577-07. Epub 2007 Jun 20.
Other Identifiers
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TTG1_081119
Identifier Type: -
Identifier Source: org_study_id