Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Chronic Hepatitis D (CHD)
Status: No longer recruiting
Protocol number: ML18788
Sponsor: Roche Romania
Company division: Pharmaceutical
Official Scientific Title: An open-label study to evaluate the effect of PEGASYS® (Peginterferon alfa-2a (40KD)) on the response rate of normal ALT and HDV RNA-negativity in patients with chronic hepatitis D
Brief summary: This study will evaluate the efficacy and safety of 48 weeks` treatment with PEGASYS monotherapy in patients with chronic hepatitis D. Treatment is followed by 24 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
40.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis D, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Reponse rate of normal ALT and HDV RNA-negativity (HDV-RNA levels) at end of follow-up (week 72).
Key secondary outcomes: 1. Efficacy: Response rate of normal ALT and HDV RNA-negativity at week 48; suppression of HBV DNA below 1x105 at weeks 48 and 72; HBsAg levels, loss of HBsAg and presence of HBsAb at weeks 48 and 72. Safety: Adverse events, laboratory parameters.
Inclusion criteria:
- adult patients, >= 18 years of age;
- positive HBsAg for >= 6 months, positive anti delta for >= 3 months and positive HDV RNA within screening period;
- liver disease consistent with chronic hepatitis D, demonstrated by liver biopsy.
Exclusion criteria:
- antiviral therapy for chronic hepatitis D within the previous 6 months;
- positive screening test for hepatitis A, hepatitis C or HIV;
- evidence of decompensated liver disease;
- history or other medical evidence of a medical condition associated with chronic liver disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2005
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Romania
- Bucharest
- Cluj-Napoca
- Constanta
- Craiova
- Iasi
- Timisoara
