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

Hepatitis D, Chronic Clinical Trial

Official title:

A Randomized, Pilot, Open-Label, Monocenter, Efficacy and Safety Study Examining the Effects of Peginterferon Alfa-2a (Pegasys) With or Without Ribavirin (Copegus) in Patients With Chronic Hepatitis D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02731131
• Other study ID #: ML18149
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2016
• Last updated: April 2, 2016
• Start date: October 2004
• Est. completion date: March 2010

Study information

• Verified date: April 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco, Ufficio Ricerca e Sperimentazione Clinica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Peginterferon alfa-2a
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
• Ribavirin
Ribavirin will be administered as 1000 to 2000 milligrams (mg) per day in divided oral doses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment		At 48 weeks after end of treatment (up to 96 weeks)	No
Secondary	Percentage of Participants with ALT Normalization Plus Negative HDV RNA at End of Treatment		At the end of treatment (up to 48 weeks)	No
Secondary	Percentage of Participants with ALT Normalization at 48 Weeks After End of Treatment		At 48 weeks after end of treatment (up to 96 weeks)	No
Secondary	Percentage of Participants with ALT Normalization at End of Treatment		At the end of treatment (up to 48 weeks)	No
Secondary	Percentage of Participants with Negative HDV RNA at 48 Weeks After End of Treatment		At 48 weeks after end of treatment (up to 96 weeks)	No
Secondary	Percentage of Participants with Negative HDV RNA at End of Treatment		At the end of treatment (up to 48 weeks)	No
Secondary	Percentage of Participants with Adverse Events		Continuously during treatment (up to 48 weeks) and through the end of follow-up (up to 96 weeks)	No