A Phase 2 interventional study of Peginterferon alfa-2a and Ribavirin in Hepatitis D, Chronic, sponsored by Hoffmann-La Roche. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-15.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 12 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive peginterferon alfa-2a alone, administered over 48 weeks.
Drug: Peginterferon alfa-2a
Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks.
Drug: Peginterferon alfa-2a · Drug: Ribavirin
Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
Also known as: Pegasys
Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
Also known as: Copegus
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.
Time frame: Week 96
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.
Time frame: Week 48
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.
Time frame: Week 96
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.
Time frame: Week 48
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.
Time frame: Week 96
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.
Time frame: Week 48
| Milestone | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 4 |
| Not completed | 0 | 2 |
| Withdrew: Psychiatric disorder | 0 | 1 |
| Withdrew: Refused therapy | 0 | 1 |
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.
| participants | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment | 0 | 1 |
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.
| participants | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | 0 | 0 |
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.
| participants | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | 3 | 1 |
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.
| participants | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| Number of Participants With ALT Normalization at End of Treatment | 1 | 0 |
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.
| participants | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | 0 | 1 |
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.
| participants | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| Number of Participants With Negative HDV RNA at End of Treatment | 1 | 2 |
Collected over Baseline through 24 weeks after end of treatment (up to 72 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: Monotherapy With Peginterferon Alfa-2a | — | 0/6 (0%) | 6/6 (100%) |
| Group B: Combination With Peginterferon Alfa-2a + Ribavirin | — | 0/6 (0%) | 6/6 (100%) |
| Event | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin |
|---|---|---|
| AstheniaGeneral disorders | 5/6 | 3/6 |
| PyrexiaGeneral disorders | 5/6 | 3/6 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/6 | 2/6 |
| MyalgiaMusculoskeletal and connective tissue disorders | 4/6 | 2/6 |
| InsomniaPsychiatric disorders | 4/6 | 3/6 |
| AnxietyPsychiatric disorders | 0/6 | 4/6 |
| HeadacheNervous system disorders | 3/6 | 2/6 |
| DepressionPsychiatric disorders | 2/6 | 3/6 |
| IrritabilityPsychiatric disorders | 2/6 | 3/6 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/6 | 2/6 |
Intent-to-Treat (ITT) Population: All participants who received at least one dose of study medication.
| Age, Continuous(years) | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | Total |
|---|---|---|---|
| Mean | 47.2 ± 9.2 | 49.2 ± 7.4 | 48.2 ± 8.0 |
| Sex: Female, Male(Participants) | Group A: Monotherapy With Peginterferon Alfa-2a | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 5 | 6 | 11 |
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche