Trial · NCT02731131
A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
NCT02731131, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD). Trials, record NCT02731131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02731131
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Peginterferon Alfa-2a With or Without Ribavirin in Participants With Chronic Hepatitis D (CHD)
- NCT number
- NCT02731131
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis D, Chronic
- Interventions
- Peginterferon alfa-2a, Ribavirin
- First posted
- 2016-04-07
- Last updated
- 2016-07-15
- Results first posted
- 2016-07-15
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment | Week 96 | 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 | Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | Week 48 | 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. |
| Secondary | Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | Week 96 | 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. |
| Secondary | Number of Participants With ALT Normalization at End of Treatment | Week 48 | 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. |
| Secondary | Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | Week 96 | 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. |
| Secondary | Number of Participants With Negative HDV RNA at End of Treatment | Week 48 | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment | Week 96 | ITT Population. | participants | NUMBER |
| SECONDARY | Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | Week 48 | ITT Population. | participants | NUMBER |
| SECONDARY | Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | Week 96 | ITT Population. | participants | NUMBER |
| SECONDARY | Number of Participants With ALT Normalization at End of Treatment | Week 48 | ITT Population. | participants | NUMBER |
| SECONDARY | Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | Week 96 | ITT Population. | participants | NUMBER |
| SECONDARY | Number of Participants With Negative HDV RNA at End of Treatment | Week 48 | ITT Population. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment | Group A: Monotherapy With Peginterferon Alfa-2a | 0 | participants | ||
| Number of Participants With Alanine Aminotransferase (ALT) Normalization Plus Negative Hepatitis D Virus (HDV) Ribonucleic Acid (RNA) at 48 Weeks After End of Treatment | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 1 | participants | ||
| Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | Group A: Monotherapy With Peginterferon Alfa-2a | 0 | participants | ||
| Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 0 | participants | ||
| Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | Group A: Monotherapy With Peginterferon Alfa-2a | 3 | participants | ||
| Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 1 | participants | ||
| Number of Participants With ALT Normalization at End of Treatment | Group A: Monotherapy With Peginterferon Alfa-2a | 1 | participants | ||
| Number of Participants With ALT Normalization at End of Treatment | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 0 | participants | ||
| Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | Group A: Monotherapy With Peginterferon Alfa-2a | 0 | participants | ||
| Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 1 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: Monotherapy With Peginterferon Alfa-2a | 6 | |
| Overall Study | STARTED | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 6 | |
| Overall Study | COMPLETED | Group A: Monotherapy With Peginterferon Alfa-2a | 6 | |
| Overall Study | COMPLETED | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 4 | |
| Overall Study | NOT COMPLETED | Group A: Monotherapy With Peginterferon Alfa-2a | 0 | |
| Overall Study | NOT COMPLETED | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 2 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Asthenia | General disorders | Group A: Monotherapy With Peginterferon Alfa-2a | 5 | 6 | |
| other | Asthenia | General disorders | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 3 | 6 | |
| other | Pyrexia | General disorders | Group A: Monotherapy With Peginterferon Alfa-2a | 5 | 6 | |
| other | Pyrexia | General disorders | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 3 | 6 | |
| other | Influenza like illness | General disorders | Group A: Monotherapy With Peginterferon Alfa-2a | 2 | 6 | |
| other | Influenza like illness | General disorders | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 1 | 6 | |
| other | Malaise | General disorders | Group A: Monotherapy With Peginterferon Alfa-2a | 1 | 6 | |
| other | Malaise | General disorders | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 0 | 6 | |
| other | Fatigue | General disorders | Group A: Monotherapy With Peginterferon Alfa-2a | 0 | 6 | |
| other | Fatigue | General disorders | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 1 | 6 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group A: Monotherapy With Peginterferon Alfa-2a | ||
| Total, all-cause mortality | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | ||
| Total, other adverse events | Group A: Monotherapy With Peginterferon Alfa-2a | 6 | 6 |
| Total, other adverse events | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 6 | 6 |
| Total, serious adverse events | Group A: Monotherapy With Peginterferon Alfa-2a | 0 | 6 |
| Total, serious adverse events | Group B: Combination With Peginterferon Alfa-2a + Ribavirin | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Group A: Monotherapy With Peginterferon Alfa-2a vs 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 | Trial comparisons |
| Group A: Monotherapy With Peginterferon Alfa-2a vs Group B: Combination With Peginterferon Alfa-2a + Ribavirin: Number of Participants With ALT Normalization Plus Negative HDV RNA at End of Treatment | Trial comparisons |
| Group A: Monotherapy With Peginterferon Alfa-2a vs Group B: Combination With Peginterferon Alfa-2a + Ribavirin: Number of Participants With Negative HDV RNA at 48 Weeks After End of Treatment | Trial comparisons |
| Group A: Monotherapy With Peginterferon Alfa-2a vs Group B: Combination With Peginterferon Alfa-2a + Ribavirin: Number of Participants With ALT Normalization at End of Treatment | Trial comparisons |
| Group A: Monotherapy With Peginterferon Alfa-2a vs Group B: Combination With Peginterferon Alfa-2a + Ribavirin: Number of Participants With ALT Normalization at 48 Weeks After End of Treatment | Trial comparisons |
| Group A: Monotherapy With Peginterferon Alfa-2a vs Group B: Combination With Peginterferon Alfa-2a + Ribavirin: Number of Participants With Negative HDV RNA at End of Treatment | Trial comparisons |
| Group A: Monotherapy With Peginterferon Alfa-2a vs Group B: Combination With Peginterferon Alfa-2a + Ribavirin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02731131
GET https://conductscience.org/api/trials/v1/NCT02731131/events?page=2