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

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Roche

Status and phase

Completed
Phase 3

Conditions

Hepatitis D, Chronic

Treatments

Drug: tenofovir
Drug: placebo
Drug: peginterferon alfa-2a [Pegasys]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01088659
ML22364

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: placebo
Drug: peginterferon alfa-2a [Pegasys]
2
Experimental group
Treatment:
Drug: tenofovir
Drug: peginterferon alfa-2a [Pegasys]

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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