Trial · NCT01318694
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) | 12 weeks after the end of treatment | SVR12 was defined as hepatitis C virus (HCV) RNA laboratory value below the level of quantification (\< LOQ; i.e., 25 IU/ml) 12 weeks after the end of treatment. |
| Secondary | Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) | 24 weeks after the end of treatment | SVR24 was defined as HCV RNA laboratory value \< LOQ 24 weeks after the end of treatment. |
| Secondary | Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4) | after 4 weeks of treatment | RVR4 was defined as serum HCV RNA \< LOQ after 4 weeks of treatment. |
| Secondary | Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment | after 12 weeks of treatment | EVR was defined as a ≥ 2 log10 decrease in HCV RNA or HCV RNA \< LOQ after 12 weeks of treatment. |
| Secondary | Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment | after 12 weeks of treatment | pEVR was defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ) after 12 weeks of treatment. |
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment | after 12 weeks of treatment | cEVR was defined as serum HCV RNA \< LOQ after 12 weeks of treatment. |
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment | from 4 to 12 weeks of treatment | eRVR was defined as achieving RVR4 and maintaining HCV RNA \< LOQ until Week 12. |
| Secondary | Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks | at treatment end within 48 weeks | ETR was defined as serum HCV RNA \< LOQ at treatment end (completed or prematurely discontinued). |
| Secondary | Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks | within 48 weeks | ALT abnormalities were summarized as participants who had either: * ALT \> 2 x upper limit of normal (ULN) during the study and \> 2 x ULN at baseline * ALT \> 3 x ULN during the study and \> 2 x ULN at baseline |
| Secondary | Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks | within 48 weeks | Grading was according to the Modified Division of Microbiology \& Infectious Diseases (DMID) Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category. |
| Secondary | Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks | within 48 weeks | Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category. |
| Secondary | Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks | within 48 weeks | Grading was according to the DMID Toxicity Tables (version 2.0). Participants with multiple abnormalities were counted only once in the worst category. |
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/NCT01318694/registered