Phase 3 N=31 Treatment

A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)

Hepatitis D, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT02732639 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2016

Primary outcome: Primary: Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 — 54.84 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Pegylated Interferon (PEG-IFN) alfa-2a (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72	54.84	—
PRIMARY Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72	61.29	—
SECONDARY Percentage of Participants With Normal ALT at Week 48	45.16	—
SECONDARY Percentage of Participants With Negative HDV RNA at Week 48	64.52	—
SECONDARY Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72	83.87; 74.19	—
SECONDARY Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels	31; 29; 26	—
SECONDARY Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72	0; 3.23	—
SECONDARY Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72	3.23; 3.23	—

Summary

This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.

Eligibility Criteria

Inclusion Criteria

Positive hepatitis B surface antigen (HBsAg) for at least 6 months prior to screening
Positive anti-delta for at least 3 months prior to screening
Positive hepatitis D virus (HDV) ribonucleic acid (RNA)
A liver biopsy obtained within the past 18 months for non-cirrhotic patients and 30 months for cirrhotic patients demonstrating liver disease consistent with chronic hepatitis D (CHD)
Negative urine or serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of test drug

Exclusion Criteria

Antiviral therapy for CHD within the previous 6 months
Positive hepatitis A, hepatitis C, or human immunodeficiency virus (HIV)
Evidence of decompensated liver disease
Other medical condition associated with chronic liver disease
Women with ongoing pregnancy or who are breast feeding

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02732639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.