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NCT Number: NCT01088659

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

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.

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Key information

Conditions

Hepatitis D, Chronic Chronic Disease Digestive System Diseases Disease Attributes Hepatitis Hepatitis D Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ankara University Medical Facility; Hepatology Department, Ankara, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon alfa-2a [Pegasys]

Drug

180mcg sc weekly, 96 weeks

Placebo

Drug

orally daily, 96 weeks

Tenofovir

Drug

245mg po daily, 96 weeks

Primary outcomes

  1. proportion of patients becoming HDV-RNA negative

    Time frame: week 96

Secondary outcomes

  1. HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology

    Time frame: weeks 48, 96 and after 24 weeks of follow-up

  2. Safety and tolerability: adverse events, laboratory parameters, vital signs

    Time frame: throughout 96 weeks of treatment

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2010
Registry last updated
Jan 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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