Trial · NCT00536263
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hepatitis B Envelope Antigen (HBe or HBeAg) Loss | 24 weeks after end of treatment (EOT) | HBeAg Loss was tested by Abbott Microparticle Enzyme Immunoassay (MEIA) |
| Secondary | Number of Participants With HBeAg Loss | Up to Treatment Week 48 | HBeAg Loss was tested by assay of Abbott MEIA |
| Secondary | HBe Seroconversion | End of treatment (EOT) and 24 weeks after EOT | HBe seroconversion was defined as HBeAg Loss and Anti-HBeAg Positive. These were tested by assay of Abbott MEIA. |
| Secondary | Number of Participants With Hepatitis B Virus - Deoxyriboncleic Acid (HBV-DNA) <20,000 IU/mL | End of treatment (EOT) and 24 weeks after EOT | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) |
| Secondary | Number of Participants With HBV-DNA < 200 IU/mL | End of treatment (EOT) and 24 weeks after EOT | HBV-DNA was tested by assay of Roche Cobas Taqman (the test lowest limit is 6 IU/mL) |
| Secondary | Number of Participants With HBV-DNA Undetectable | End of treatment (EOT) and 24 weeks after EOT | Undetectable HBV-DNA was defined as having a level \<6 IU/mL by polymerase chain reaction (PCR). |
| Secondary | Number of Participants With Biochemical Response | End of treatment (EOT) and 24 weeks after EOT | Biochemical response was defined as alanine aminotransferase (ALT) normalization. |
| Secondary | Number of Participants With Combined Response | End of treatment (EOT) and 24 weeks after EOT | Combined response was defined as HBV DNA \<20,000 IU/mL and HBe seroconversion and alanine aminotransferase (ALT) normalization |
| Secondary | Hepatitis B Surface Antigen (HBsAg) Loss | End of treatment (EOT) and 24 weeks after EOT | HBsAg Loss was tested by assay of Abbott MEIA |
| Secondary | Hepatitis B Surface Antigen (HBs) Seroconversion | End of treatment (EOT) and 24 weeks after EOT | HBs seroconversion was defined as having HBsAg Loss and Anti-HBs Positive |
| Secondary | Change From Baseline in Liver Biopsy Score | Baseline to 24 weeks after end of treatment | Method for biopsy scoring was Knodell Scoring System (Histology Activity Index-HAI Score System): Score I (periportal +/- bridging necrosis): 0 (none) to 10 (multilobular necrosis). Score II (Intralobular degeneration and focal necrosis): 0 (none) to 4 (Marked \[involvement of \>2/3 of lobules or nodules\]). Score III (portal inflammation): 0 (none) to 4 (Marked \[dense packing of inflammatory cells in \>2/3 of portal tracts\]). Score IV (fibrosis): 0 (none) to 4 (cirrhosis). |
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/NCT00536263/registered