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

Hepatitis D, Chronic Clinical Trial

Official title:

Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732639
• Other study ID #: ML18788
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2016
• Last updated: April 5, 2016
• Start date: October 2005
• Est. completion date: December 2008

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Agency for Medicines and Medical Devices
• Study type: Interventional

Clinical Trial Summary

This study will evaluate 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 will be followed by 24 weeks of treatment-free follow-up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis D
• Hepatitis D, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Pegylated Interferon (PEG-IFN) alfa-2a
Participants will receive pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Normal Alanine Aminotransferase (ALT) and Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA)		At Week 72	No
Secondary	Percentage of Participants with Normal ALT and Negative HDV RNA		At Week 48	No
Secondary	Percentage of Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 copies/milliliter (mL)		At Weeks 48 and 72	No
Secondary	Absolute Hepatitis B Surface Antigen (HBsAg) Levels		At Weeks 48 and 72	No
Secondary	Percentage of Participants with HBsAg Seronegative and Positive Hepatitis B Surface Antibody (HBsAb)		At Weeks 48 and 72	No