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HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis

NCT00932971 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2018-01-29

No results posted yet for this study

Summary

Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.

Conditions

  • Hepatitis D

Interventions

DRUG

PEG-IFN alfa-2a, Tenofovir

Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally

DRUG

PEG-IFN alfa-2a, placebo

Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally

Sponsors & Collaborators

  • Hannover Medical School

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Gilead Sciences

    collaborator INDUSTRY

  • HepNet Study House, German Liverfoundation

    lead NETWORK

Principal Investigators

  • Michael P. Manns, Prof. Dr. · Hannover Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2017-08-31
Completion
2017-08-02

Countries

  • Germany
  • Greece
  • Romania

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932971 on ClinicalTrials.gov