Individualized Duration of Peg-interferon/Ribavirin Treatment of Hepatitis C

Chronic Hepatitis C, Genotype 1 Clinical Trial

— TTG1  

Official title:

Tailored Treatment of Hepatitis C Genotype 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910975
• Other study ID #: TTG1_081119
• Status: Completed
• Phase: Phase 4
• First received: May 28, 2009
• Last updated: September 3, 2012
• Start date: November 2007
• Est. completion date: September 2011

Study information

• Verified date: September 2012
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C, Genotype 1
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	Vastra Gotaland

Sponsors (8)

Lead Sponsor	Collaborator
Göteborg University	Karolinska University Hospital, Lund University Hospital, Sahlgrenska University Hospital, Sweden, Skane University Hospital, Skaraborg Hospital, Sodra Alvsborgs Hospital, Uddevalla Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Lindh M, Alestig E, Arnholm B, Eilard A, Hellstrand K, Lagging M, Wahlberg T, Wejstål 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. Epub 2007 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication dose per cured patient		26 weeks after end of treatment	No
Secondary	Sustained virological response and relapse rate		26 weeks after end of treatment	No