Back to resultsA Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
Primary Purpose
Hepatitis D, Chronic
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Peginterferon alfa-2a
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis D, Chronic
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A: Monotherapy with Peginterferon alfa-2a
Group B: Combination with Peginterferon alfa-2a + Ribavirin
Arm Description
Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.
Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.
Number of Participants With ALT Normalization at 48 Weeks After End of Treatment
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.
Number of Participants With ALT Normalization at End of Treatment
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.
Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.
Number of Participants With Negative HDV RNA at End of Treatment
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02731131
Brief Title
A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis D, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: Monotherapy with Peginterferon alfa-2a
Arm Type
Experimental
Arm Description
Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.
Arm Title
Group B: Combination with Peginterferon alfa-2a + Ribavirin
Arm Type
Experimental
Arm Description
Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Peginterferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
Primary Outcome Measure Information:
Title
Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment
Description
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.
Time Frame
Week 96
Secondary Outcome Measure Information:
Title
Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment
Description
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with ALT normalization and negative HDV RNA at Week 48 was reported.
Time Frame
Week 48
Title
Number of Participants With ALT Normalization at 48 Weeks After End of Treatment
Description
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). The number of participants with ALT normalization at Week 96 was reported.
Time Frame
Week 96
Title
Number of Participants With ALT Normalization at End of Treatment
Description
Normalized ALT was defined as ALT value above the ULN at Baseline with a decrease in ALT value to at/below the ULN at the end of treatment (Week 48). The number of participants with ALT normalization at Week 48 was reported.
Time Frame
Week 48
Title
Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment
Description
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at 48 weeks after end of treatment (Week 96) was reported.
Time Frame
Week 96
Title
Number of Participants With Negative HDV RNA at End of Treatment
Description
Negative HDV RNA was defined as HDV RNA not detected by PCR. The number of participants with negative HDV RNA at the end of treatment (Week 48) was reported.
Time Frame
Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Chair
Facility Information:
City
Cagliari
ZIP/Postal Code
09042
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
We'll reach out to this number within 24 hrs