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A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01088659
First received: March 16, 2010
Last updated: June 5, 2017
Last verified: June 2017
  Purpose
This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.

Condition Intervention Phase
Hepatitis D, Chronic Drug: peginterferon alfa-2a [Pegasys] Drug: placebo Drug: tenofovir Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • proportion of patients becoming HDV-RNA negative [ Time Frame: week 96 ]

Secondary Outcome Measures:
  • HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology [ Time Frame: weeks 48, 96 and after 24 weeks of follow-up ]
  • Safety and tolerability: adverse events, laboratory parameters, vital signs [ Time Frame: throughout 96 weeks of treatment ]

Enrollment: 50
Actual Study Start Date: February 16, 2010
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly, 96 weeks
Drug: placebo
orally daily, 96 weeks
Experimental: 2 Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly, 96 weeks
Drug: tenofovir
245mg po daily, 96 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >/=18 years of age
  • chronic hepatitis D
  • positive for HBsAg >/=6 months, for anti-HDV >/=3 months and for HDV-RNA at screening
  • negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study

Exclusion Criteria:

  • antiviral therapy for chronic hepatitis D within the previous 6 months
  • previous therapy with pegylated interferon alfa
  • treatment with conventional interferon alfa for >12 months
  • hepatitis A or C, or HIV infection
  • decompensated liver disease (Childs B-C)
  • history or evidence of medical condition associated with chronic liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088659

Locations
Turkey
Ankara University Medical Facility; Hepatology Department
Ankara, Turkey, 06620
Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
Bursa, Turkey, 16059
Dicle Uni Medical Faculty; Gastroenterology
Diyarbakir, Turkey, 10000
Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
Istanbul, Turkey, 34390
Ege Uni Medical Faculty Izmir; Gastroenterology
Izmir, Turkey, 35100
Dokuz Eylul University Medical Faculty; Infection
Izmir, Turkey, 35340
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01088659     History of Changes
Other Study ID Numbers: ML22364
Study First Received: March 16, 2010
Last Updated: June 5, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis D
Hepatitis D, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Tenofovir
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017