Clinical trial NCT00308048: 14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response
Official title: 14 vs 24 Weeks HCV Treatment to Genotype 2/3 Patients With Rapid Virological Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Keywords: Interferon
Pegylated interferon
Pegylated interferon alfa 2b
Hepatitis C
Genotype 2
Genotype 3
Rapid virological response
Short treatment
14 weeks treatment
health related quality of life
sick leave
Injecting drug use
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2006-03-28
Enrollment: 435
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with HCV genotype 2 or 3 infection who have a rapid virological response to treatment are randomised to either 14 or 24 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Detailed description: Patients with HCV genotype 2 or 3 infection are currently recommended 6 months treatment with pegylated interferon alfa (2a or 2b) and ribavirin.Approximately 80% obtain sustained virological response (HCV RNA undetectable 6 months after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in econimical terms. Increasing the treatment duration beyond 6 months does not increase the response rate. Shorter treatment has only been assessed in small trials, but the results have been encouraging.

In this randomised, open label,multicenter phase 3 trial with acitive controls patients are treated with pegylated interferon alfa 2a (PegIntron (R), Schering Plough NJ)(1,5 mcg/kg)and ribavirin (Rebetol (R), Schering Plough, NJ) (800-1400mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (\<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 10 or 20 weeks combination treatment. Patients who are HCV RNA positive are all treated for 20 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.

Our hypothesis is that there is no important difference in the effect in the two groups.

This is a non-inferiority trial. The smallest difference considered to be clinically important is 10%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.

Eligibility criteria: Inclusion Criteria:

HCV RNA positive Genotype 2 or 3 Treatment naive Raised ALT

-

Exclusion Criteria:

Active substance abuse Poorly controlled psychiatric disease Decompensated cirrhosis HBsAg positive Anti-HIV positive Suffering from other significant concurrent medical conditions including chronic liver diseases -

Primary outcomes:
measure: Sustained virological response (SVR) =HCV RNA negativity (<20 IU/ml) six months after end of treatment.
Secondary outcomes:
measure: Change in health related quality as measured by short from 36 (SF-36) from baseline to 6 months after end of treatment.
measure: Sick leave in patients treated for 14 or 24 weeks treatment
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevaal University Hospital
Study officials:
affiliation: Ullevaal University Hospital, Oslo, Norway
name: Olav Dalgard, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalgard O, Bjoro K, Hellum KB, Myrvang B, Ritland S, Skaug K, Raknerud N, Bell H. Treatment with pegylated interferon and ribavarin in HCV infection with genotype 2 or 3 for 14 weeks: a pilot study. Hepatology. 2004 Dec;40(6):1260-5. doi: 10.1002/hep.20467.