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

NCT02731131 | Completed Phase 2 Results

• 1 other identifier: ML18149
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis D, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment

  Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.

  Week 96

Secondary Outcomes (5)

• Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment

  Week 48

• Number of Participants With ALT Normalization at 48 Weeks After End of Treatment

  Week 96

• Number of Participants With ALT Normalization at End of Treatment

  Week 48

• Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment

  Week 96

• Number of Participants With Negative HDV RNA at End of Treatment

  Week 48

Study Arms (2)

Group A: Monotherapy with Peginterferon alfa-2a

EXPERIMENTAL

Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.

Drug: Peginterferon alfa-2a

Group B: Combination with Peginterferon alfa-2a + Ribavirin

EXPERIMENTAL

Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.

Drug: Peginterferon alfa-2a; Drug: Ribavirin

Interventions

Peginterferon alfa-2a DRUG

Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.

Also known as: Pegasys

Group A: Monotherapy with Peginterferon alfa-2a; Group B: Combination with Peginterferon alfa-2a + Ribavirin

Ribavirin DRUG

Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.

Also known as: Copegus

Group B: Combination with Peginterferon alfa-2a + Ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Cagliari, 09042, Italy

Location

MeSH Terms

Conditions

Hepatitis D, Chronic

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Hepatitis D; Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: April 7, 2016
• Study Start: September 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 15, 2016
• Results First Posted: July 15, 2016

Record last verified: 2016-06

Locations

IT (1)