Trial · NCT01369212
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
NCT01369212, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2022-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B. Trials, record NCT01369212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01369212
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
- NCT number
- NCT01369212
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 201 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Hepatitis B
- Interventions
- Tenofovir, Peginterferon-alfa 2a and tenofovir
- First posted
- 2011-06-08
- Last updated
- 2023-04-28
- Results first posted
- 2022-10-12
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 | Week 240 | Estimated percent of participants who became HBsAg negative by week 240 from randomization |
| Secondary | Cumulative Percent of Participants With HBsAg Loss at Week 192 | Week 192 | Cumulative percentage of participants with HBsAg loss at week 192 estimated using Kaplan-Meier method |
| Secondary | Number of Participants With Serious Adverse Events | Up to 240 weeks | Number of participants with at least one serious adverse event between randomization and week 240 |
| Secondary | Number of Participants With Adverse Events | up to 240 weeks | Number of participants with at least one adverse event between randomization and week 240 |
| Secondary | Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192 | week 192 | Number of participants who became Hepatitis B e antigen (HBeAg) negative at week 192 among HBeAg positive participants at randomization (baseline) |
| Secondary | Number of Participants With HBeAg Loss at Week 240 | week 240 | Number of participants who became HBeAg negative at week 240 among HBeAg positive participants at baseline |
| Secondary | Number of Participants With HBsAg Seroconversion at Week 192 | week 192 | Number of participants who became with HBsAg negative and developed anti-HBs at week 192 |
| Secondary | Number of Participants With HBsAg Seroconversion at Week 240 | week 240 | Number of participants who became HBsAg negative and developed anti-HBs at week 240 |
| Secondary | Number of Participants With HBeAg Seroconversion at Week 192 | week 192 | Number of participants who became HBeAg negative and developed anti-HBe at week 192 among HBeAg positive participants at baseline |
| Secondary | Number of Participants With HBeAg Seroconversion at Week 240 | week 240 | Number of participants who became HBeAg negative and developed anti-HBe at week 240 among HBeAg positive participants at baseline |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 | Week 240 | This outcome is analyzed as a survival outcome with proportion estimated at week 240 using Kaplan-Meier Method | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Percent of Participants With HBsAg Loss at Week 192 | Week 192 | Cumulative percentage of participants | NUMBER | |
| SECONDARY | Number of Participants With Serious Adverse Events | Up to 240 weeks | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events | up to 240 weeks | All randomized participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192 | week 192 | Among HBeAg positive participants at baseline who had HBeAg data available at week 192 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HBeAg Loss at Week 240 | week 240 | Participants who were HBeAg positive at baseline and who had data for HBeAg at week 240 visit | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HBsAg Seroconversion at Week 192 | week 192 | Participants with data on HBsAg and anti-HBs at week 192 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HBsAg Seroconversion at Week 240 | week 240 | HBsAg and antiHBs data at week 240 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HBeAg Seroconversion at Week 192 | week 192 | HBeAg positives at baseline with HBeAg and anti-HBe data available at week 192 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HBeAg Seroconversion at Week 240 | week 240 | HBeAg positive participants at baseline with HBeAg and anti-HBe data at week 240 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 | Tenofovir | 4.1 | Percentage of participants | ||
| Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240 | Peginterferon-alfa 2a and Tenofovir | 5.2 | Percentage of participants | ||
| Cumulative Percent of Participants With HBsAg Loss at Week 192 | Tenofovir | 1.0 | Cumulative percentage of participants | ||
| Cumulative Percent of Participants With HBsAg Loss at Week 192 | Peginterferon-alfa 2a and Tenofovir | 5.2 | Cumulative percentage of participants | ||
| Number of Participants With Serious Adverse Events | Tenofovir | 11 | Participants | ||
| Number of Participants With Serious Adverse Events | Peginterferon-alfa 2a and Tenofovir | 7 | Participants | ||
| Number of Participants With Adverse Events | Tenofovir | 50 | Participants | ||
| Number of Participants With Adverse Events | Peginterferon-alfa 2a and Tenofovir | 60 | Participants | ||
| Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192 | Tenofovir | 14 | Participants | ||
| Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192 | Peginterferon-alfa 2a and Tenofovir | 29 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tenofovir | 102 | |
| Overall Study | STARTED | Peginterferon-alfa 2a and Tenofovir | 99 | |
| Overall Study | COMPLETED | Tenofovir | 95 | |
| Overall Study | COMPLETED | Peginterferon-alfa 2a and Tenofovir | 92 | |
| Overall Study | NOT COMPLETED | Tenofovir | 7 | |
| Overall Study | NOT COMPLETED | Peginterferon-alfa 2a and Tenofovir | 7 |
Source ClinicalTrials.gov
Adverse events384
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 | ANEMIA | Blood and lymphatic system disorders | Tenofovir | 1 | 102 | 1 |
| other | ANEMIA | Blood and lymphatic system disorders | Peginterferon-alfa 2a and Tenofovir | 3 | 99 | 3 |
| other | BETA-THALESSEMIA, ANEMIA | Blood and lymphatic system disorders | Tenofovir | 1 | 102 | 1 |
| other | BETA-THALESSEMIA, ANEMIA | Blood and lymphatic system disorders | Peginterferon-alfa 2a and Tenofovir | 0 | 99 | 0 |
| other | HYPOPHOSPHATEMIA | Blood and lymphatic system disorders | Tenofovir | 0 | 102 | 0 |
| other | HYPOPHOSPHATEMIA | Blood and lymphatic system disorders | Peginterferon-alfa 2a and Tenofovir | 2 | 99 | 3 |
| other | IRON DEFICIENCY DEVELOPED WITHOUT ANEMIA | Blood and lymphatic system disorders | Tenofovir | 1 | 102 | 1 |
| other | IRON DEFICIENCY DEVELOPED WITHOUT ANEMIA | Blood and lymphatic system disorders | Peginterferon-alfa 2a and Tenofovir | 0 | 99 | 0 |
| other | LOW ANC | Blood and lymphatic system disorders | Tenofovir | 0 | 102 | 0 |
| other | LOW ANC | Blood and lymphatic system disorders | Peginterferon-alfa 2a and Tenofovir | 1 | 99 | 1 |
1 to 10 of 384Source ClinicalTrials.gov
See all 384 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenofovir | 0 | 102 |
| Total, all-cause mortality | Peginterferon-alfa 2a and Tenofovir | 0 | 99 |
| Total, other adverse events | Tenofovir | 50 | 102 |
| Total, other adverse events | Peginterferon-alfa 2a and Tenofovir | 60 | 99 |
| Total, serious adverse events | Tenofovir | 11 | 102 |
| Total, serious adverse events | Peginterferon-alfa 2a and Tenofovir | 7 | 99 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants19
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30DK050306 | Center for Molecular Studies in Digestive and Liver Diseases | CADWELL, KEN HASHIGIWA | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 1997 to 2025 | NIH RePORTER |
| U01DK082863 | Hepatitis B Clinical Research Network Clinical Center: Michigan - Hawaii Consortium | LOK, ANNA S.F. | UNIVERSITY OF MICHIGAN AT ANN ARBOR | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2020 | NIH RePORTER |
| U01DK082864 | Hepatitis B Research Network - Data Coordination Center | BELLE, STEVEN H. | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
| U01DK082867 | North Carolina Hepatitis B Research Network | FRIED, MICHAEL W | UNIV OF NORTH CAROLINA CHAPEL HILL | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
| U01DK082871 | Midwest Hepatitis B Consortium | DI BISCEGLIE, ADRIAN MICHAEL | SAINT LOUIS UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
| U01DK082872 | Hepatitis B Research Network Clinical Centers | LEE, WILLIAM M | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
| U01DK082874 | Observation Study of Persons with Chronic Hepatitis B Virus infection in North America | JANSSEN, HARRY | UNIVERSITY HEALTH NETWORK | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
| U01DK082919 | Harvard Hepatitis B Consortium | LAU, DARYL T; CHUNG, RAYMOND T | BETH ISRAEL DEACONESS MEDICAL CENTER | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
| U01DK082923 | Hepatitis B Clinical Research Network | STERLING, RICHARD K. | VIRGINIA COMMONWEALTH UNIVERSITY | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
| U01DK082944 | Hepatitis B Research Network (HBRN): Natural History and Treatment Studies | KHALILI, MANDANA; COOPER, STEWART; TERRAULT, NORAH A. | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES | 2008 to 2019 | NIH RePORTER |
1 to 10 of 19
See all 19 grantsTrial comparisons17
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With HBeAg Seroconversion at Week 192 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With HBsAg Seroconversion at Week 192 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With HBeAg Seroconversion at Week 240 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With Serious Adverse Events | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With HBV DNA<1000 IU/mL at Week 240 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With HBV DNA<1000 IU/mL at Week 192 | Trial comparisons |
| Tenofovir vs Peginterferon-alfa 2a and Tenofovir: Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192 | Trial comparisons |
1 to 10 of 17
See all 17 trial comparisonsTests0
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/NCT01369212
GET https://conductscience.org/api/trials/v1/NCT01369212/results?page=2