Trial · NCT01718158
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12) | Post treatment follow-up Week 12 | |
| Secondary | Proportion of subjects who achieve SVR12 in treatment-naive subjects | Post treatment follow-up Week 12 | |
| Secondary | Proportion of subjects with rash related dermatologic events | Up to 12 weeks of treatment | |
| Secondary | Proportion of subjects who develop treatment emergent cytopenic abnormalities | Up to 48 Weeks | Treatment emergent cytopenic abnormalities \[anemia as defined by Hemoglobin (Hb) \< 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) \< 750/mm3, and or thrombocytopenia as defined by platelets \< 50,000/mm3\] |
| Secondary | Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms | Up to 48 Weeks | |
| Secondary | Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24 | Post treatment follow-up Week 24 | SVR24 = Sustained virologic response at post treatment follow-up Week 24 |
| Secondary | Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up | Maximum of 72 weeks | |
| Secondary | Proportion of subjects who achieve SVR12 with a 24-week treatment regimen | Post treatment follow-up Week 12 | |
| Secondary | Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment) | Weeks 4 and 12 of treatment | |
| Secondary | Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up | Maximum of 72 weeks | |
| Secondary | Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT) | Maximum of 72 weeks | |
| Secondary | Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT | Maximum of 48 weeks | Psychiatric symptoms (depression, irritability or insomnia) |
| Secondary | Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses | Post-treatment follow-up Week 12 | For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen |
| Secondary | Resistant variants associated with virologic failure through end of follow-up | Maximum of 72 weeks |
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/NCT01718158/registered