Trial · NCT01369212
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| 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 |
| Secondary | Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192 | week 192 | Number of participants with normal alanine transaminase (ALT) levels at week 192 (Normal ALT for males ≤30 U/L, for females ≤20 U/L) |
| Secondary | Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240 | week 240 | Number of participants with normal alanine transaminase (ALT) levels \[males ≤30 U/L, for females ≤20 U/L\] at week 240 |
| Secondary | Number of Participants With HBV DNA<1000 IU/mL at Week 192 | week 192 | Number of participants with HBV DNA \<1000 IU/mL at week 192 |
| Secondary | Number of Participants With HBV DNA<1000 IU/mL at Week 240 | week 240 | Number of participants with HBV DNA \<1000 IU/mL at week 240 |
| Secondary | Number of Participants With HBV DNA<20 IU/mL at Week 192 | week 192 | Number of participants with HBV DNA\<20 IU/mL at week 192 |
| Secondary | Number of Participants With HBV DNA<20 IU/mL at Week 240 | week 240 | Number of participants with HBV DNA\<20 IU/mL at week 240 |
| Secondary | Absence of Detectable Antiviral Drug-Resistant HBV Mutations at Week 192 | week 192 | Absence of detectable antiviral drug-resistant HBV mutations at Week 192 |
| Secondary | Cumulative Percent of Participants With HBsAg Loss at Week 240 | Week 240 | Cumulative percent of participants with HBsAg loss at week 240 estimated using Kaplan-Meier method |
| Secondary | Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192 | week 192 | Number of participants with alanine transaminase(ALT) levels \<= 38 U/L for males and \<=25 for females at week 192. The cut-offs 38 and 25 are approximately 1.25 times the upper limit of normal (30 U/L for males and 20 U/L for females) respectively. |
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.
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GET https://conductscience.org/api/trials/v1/NCT01369212/registered