Phase 3
Completed N=31
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
Hepatitis D, Chronic
Source: ClinicalTrials.gov NCT02732639 ↗
Enrolled (actual)
31
Serious AEs
—
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 — 54.84 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.