Trial · NCT02732639
A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
NCT02732639, Phase 3, Completed, Hoffmann-La Roche; results first posted 2016-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD). Trials, record NCT02732639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02732639
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pegylated Interferon (PEG-IFN) Alfa-2a (Pegasys) in Participants With Chronic Hepatitis D (CHD)
- NCT number
- NCT02732639
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 31 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis D, Chronic
- Interventions
- Pegylated Interferon (PEG-IFN) alfa-2a
- First posted
- 2016-04-08
- Last updated
- 2016-08-26
- Results first posted
- 2016-08-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | At Week 72 | Samples were collected and analyzed for ALT. A normal ALT is a value within the normal range of the assay. |
| Primary | Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | 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 | Percentage of Participants With Normal ALT at Week 48 | At Week 48 | Samples were collected and analyzed for ALT levels. A normal ALT is a value within the normal range of the assay. |
| Secondary | Percentage of Participants With Negative HDV RNA at Week 48 | 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. |
| Secondary | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | 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. |
| Secondary | Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | At Screening and at Weeks 48 and 72 | Samples were collected and analyzed for HBsAg. Positive HBsAg levels are defined as levels above the level of detection of the assay. |
| Secondary | Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | 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. |
| Secondary | Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | At Week 72 | Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | At Week 72 | Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normal ALT at Week 48 | At Week 48 | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Negative HDV RNA at Week 48 | At Week 48 | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | At Weeks 48 and 72 | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | At Screening and at Weeks 48 and 72 | Intention-to-treat (ITT) analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | At Weeks 48 and 72 | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Positive Hepatitis B Surface Antibody (HBsAb) at Weeks 48 and 72 | At Weeks 48 and 72 | ITT analysis population included all participants, who received at least one dose of the study medication and had a subsequent post baseline assessment. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 72 | Pegylated Interferon (PEG-IFN) Alfa-2a | 54.84 | 95% Confidence Interval 37.3 to 72.4 | percentage of participants | |
| Percentage of Participants With Negative Hepatitis D Virus Ribonucleic Acid (HDV RNA) at Week 72 | Pegylated Interferon (PEG-IFN) Alfa-2a | 61.29 | 95% Confidence Interval 44.1 to 78.4 | percentage of participants | |
| Percentage of Participants With Normal ALT at Week 48 | Pegylated Interferon (PEG-IFN) Alfa-2a | 45.16 | 95% Confidence Interval 27.6 to 62.7 | percentage of participants | |
| Percentage of Participants With Negative HDV RNA at Week 48 | Pegylated Interferon (PEG-IFN) Alfa-2a | 64.52 | 95% Confidence Interval 47.7 to 81.4 | percentage of participants | |
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | Pegylated Interferon (PEG-IFN) Alfa-2a | HBV-DNA at Week 48 | 83.87 | 95% Confidence Interval 70.9 to 96.8 | percentage of participants |
| Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Below 1*10^5 Copies/Milliliter (mL) at Weeks 48 and 72 | Pegylated Interferon (PEG-IFN) Alfa-2a | HBV-DNA at Week 72 | 74.19 | 95% Confidence Interval 58.8 to 89.6 | percentage of participants |
| Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | Pegylated Interferon (PEG-IFN) Alfa-2a | HBsAg Positive at Screening | 31 | participants | |
| Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | Pegylated Interferon (PEG-IFN) Alfa-2a | HBsAg Positive at Week 48 | 29 | participants | |
| Number of Participants With Positive Hepatitis B Surface Antigen (HBsAg) Levels | Pegylated Interferon (PEG-IFN) Alfa-2a | HBsAg Positive at Week 72 | 26 | participants | |
| Percentage of Participants With HBsAg Seronegative at Weeks 48 and 72 | Pegylated Interferon (PEG-IFN) Alfa-2a | Seronegative HBsAg at Week 48 | 0 | 95% Confidence Interval NA to NA | percentage of participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegylated Interferon (PEG-IFN) Alfa-2a | 31 | |
| Overall Study | COMPLETED | Pegylated Interferon (PEG-IFN) Alfa-2a | 30 | |
| Overall Study | NOT COMPLETED | Pegylated Interferon (PEG-IFN) Alfa-2a | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegylated Interferon (PEG-IFN) Alfa-2a | ||
| Total, other adverse events | Pegylated Interferon (PEG-IFN) Alfa-2a | 0 | 0 |
| Total, serious adverse events | Pegylated Interferon (PEG-IFN) Alfa-2a | 0 | 0 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02732639
GET https://conductscience.org/api/trials/v1/NCT02732639/registered