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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: May 7, 2013
Last verified: May 2013
History of Changes
  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: tenofovir
Drug: placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • proportion of patients becoming HDV-RNA negative [ Time Frame: week 96 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Safety and tolerability: adverse events, laboratory parameters, vital signs [ Time Frame: throughout 96 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088659

Locations
Turkey
Ankara, Turkey, 06620
Bursa, Turkey, 16059
Diyarbakir, Turkey, 10000
Istanbul, Turkey, 34390
Izmir, Turkey, 35340
Izmir, Turkey, 35100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: May 7, 2013
Health Authority: Turkey: Ministry of Health

Additional relevant MeSH terms:
Hepatitis D
Hepatitis
Hepatitis A
Hepatitis D, Chronic
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Enterovirus Infections
Picornaviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferon Alfa-2a
Tenofovir
 Tenofovir disoproxil
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013