Trial · NCT01277601
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With 48 Weeks of TDF Plus Peg-IFN Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. Participants in the TDF+Peg-IFN 48 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed by randomized treatment. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Loss at Week 72 Following Treatment With TDF (48 Weeks) Plus Peg-IFN (16 Weeks) Combination Versus Peg-IFN Alone for 48 Weeks or TDF Alone | Baseline; Week 72 | Full Analysis Set. Participants in the TDF 48 week + Peg-IFN 16 Weeks, TDF 120 Weeks, and Peg-IFN 48 Weeks groups were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Loss at Weeks 96 and 120 | Baseline; Weeks 96 and 120 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBsAg Seroconversion at Weeks 72, 96, and 120 | Baseline; Weeks 72, 96, and 120 | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss and Seroconversion at Week 72 | Baseline; Week 72 | Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss and Seroconversion at Week 96 | Baseline; Week 96 | Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HBeAg Loss and Seroconversion at Week 120 | Baseline; Week 120 | Participants in the Full Analysis Set who were HBeAg reactive or indeterminate at baseline were analyzed. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the outcome. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 72 | Week 72 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 96 | Week 96 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response (HBV DNA < 117 IU/mL) at Week 120 | Week 120 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normal ALT at Week 72 | Week 72 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normal ALT at Week 96 | Week 96 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normal ALT at Week 120 | Week 120 | Full Analysis Set. The missing = failure method was used in which participants on study with missing data were considered to have failed to achieve the endpoint. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Required Retreatment | Up to 120 weeks | Safety Analysis Set. Participants in the TDF+Peg-IFN 48 Weeks, TDF 48 Weeks + Peg-IFN 16 Weeks, and Peg-IFN 48 Weeks groups were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01277601/outcomes