Phase 2 N=12 Randomized Treatment

A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)

Hepatitis D, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT02731131 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment — 0; 1 participants — p=0.30

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Peginterferon alfa-2a (Drug); Ribavirin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment	0; 1	0.30
SECONDARY Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment	0; 0	—
SECONDARY Number of Participants With ALT Normalization at 48 Weeks After End of Treatment	3; 1	0.22
SECONDARY Number of Participants With ALT Normalization at End of Treatment	1; 0	0.30
SECONDARY Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment	0; 1	0.30
SECONDARY Number of Participants With Negative HDV RNA at End of Treatment	1; 2	0.50

Summary

This single-center, randomized, open-label, pilot study is designed to evaluate the efficacy and safety of 48 weeks of treatment with peginterferon alfa-2a alone versus in combination with ribavirin in participants with CHD.

Eligibility Criteria

Inclusion Criteria

Positive hepatitis B surface antigen (HBsAg) for the prior 6 months
Positive anti-delta for the prior 3 months
Positive HDV RNA at Screening
Elevated ALT (1 to 10 times upper limit of normal) prior to first dose
Chronic, necroinflammatory hepatitis documented within the prior 18 months (non-cirrhotic) or 30 months (cirrhotic)
Negative pregnancy and adequate contraceptive use

Exclusion Criteria

Antiviral therapy for CHD within previous 3 months
Positive for hepatitis A or C, or human immunodeficiency virus (HIV)
Increased risk of metabolic liver disease
Decompensated liver disease
Elevated bilirubin
Poor hematologic or renal function
Drug/alcohol abuse within 1 year prior to study
History of significant psychiatric, autoimmune, pulmonary, cardiac, oncologic, or thyroid disease
Organ transplantation with existing functional graft
Retinopathy or other ophthalmologic complication of diabetes or hypertension
Inclusion in another investigational trial within previous 12 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02731131). 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.