Back to resultsA Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
Primary Purpose
Hepatitis D, Chronic
Status
Completed
Phase
Phase 3
Locations
Romania
Study Type
Interventional
Intervention
Pegylated Interferon (PEG-IFN) alfa-2a
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pegylated Interferon (PEG-IFN) alfa-2a
Arm Description
Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Outcomes
Primary Outcome Measures
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Secondary Outcome Measures
Percentage of Participants With Normal ALT at Week 48
Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.
Percentage of Participants With Negative HDV RNA at Week 48
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72
Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.
Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.
Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.
Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02732639
Brief Title
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
Official Title
Open-label, Multicenter, Trial Evaluating Efficacy and Safety of Peginterferon Alfa-2a (PEGASYS®) in Patients With Chronic Hepatitis D (CHD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (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 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.
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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pegylated Interferon (PEG-IFN) alfa-2a
Arm Type
Experimental
Arm Description
Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon (PEG-IFN) alfa-2a
Other Intervention Name(s)
PEGASYS
Intervention Description
Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72
Description
Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay.
Time Frame
At Week 72
Title
Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72
Description
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Time Frame
At Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants With Normal ALT at Week 48
Description
Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay.
Time Frame
At Week 48
Title
Percentage of Participants With Negative HDV RNA at Week 48
Description
Samples were collected and analyzed for HDV RNA levels. Negative HDV RNA is defined as below the level of detection of the assay.
Time Frame
At Week 48
Title
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72
Description
Samples were collected and analyzed for HBV DNA levels. Reported here is the percentage of participants with HBV DNA levels below 1*10^5 copies/mL.
Time Frame
At Weeks 48 and 72
Title
Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels
Description
Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay.
Time Frame
At Screening and at Weeks 48 and 72
Title
Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72
Description
Samples were collected and analyzed for HBsAg. Seronegative HBsAg is defined as below the level of detection of the assay.
Time Frame
At Weeks 48 and 72
Title
Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72
Description
Samples were collected and analyzed for HBsAb. Positive HBsAb levels are defined as levels above the level of detection of the assay and reflect the presence of antibodies produced against HBsAg.
Time Frame
At Weeks 48 and 72
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 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
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
Bucharest
ZIP/Postal Code
021105
Country
Romania
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
City
Cluj-napoca
ZIP/Postal Code
400162
Country
Romania
City
Constanta
Country
Romania
City
Craiova
Country
Romania
City
Iasi
ZIP/Postal Code
700111
Country
Romania
City
Timisoara
ZIP/Postal Code
293406
Country
Romania
12. IPD Sharing Statement
Learn more about this trial
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
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