Trial · NCT01866930
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Follow-up week 12 | SVR12 was defined as HCV RNA less than lower limit of quantification (\< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12. |
| Secondary | Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Treatment weeks 4 and 12 | RVR is defined as HCV RNA \< LLOQ target not detected at Week 4 and eRVR defined as HCV RNA \< LLOQ target not detected at Weeks 4 and 12 |
| Secondary | Number of Subjects With Sustained Virologic Response at Post-treatment Week 24 (SVR24) | Follow-up week 24 | SVR24 was defined as HCV RNA \< LLOQ (25 IU/mL; target detected or not detected) at 24 weeks post treatment. |
| Secondary | Number of Participants With Treatment Emergent Cytopenic Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | All treated participants were monitored for 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) during the treatment period (Weeks 1, 2, 4, 6, 8, 12, 20, and 24, and at Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits). |
| Secondary | Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms | After Day 1 to end of treatment; up to Weeks 24 or 48 | All treated participants were monitored for IFN-associated Flu-like and Musculoskeletal symptoms. Flu-like symptoms were defined as pyrexia, chills, or pain. Musculoskeletal symptoms were defined as arthralgia, myalgia, or back pain. Subjects were monitored throughout the treatment period during the treatment period (After day 1 up to week 24, or After day 1 up to week 48 for subjects requiring those visits). |
| Secondary | Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs) | After Day 1 to end of treatment; up to Weeks 24 or 48 | AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that. at any dose, results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. |
| Secondary | Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | Grade 3/4 treatment-emergent lab abnormalities that occurred in \>=5% of subjects in either cohort are reported. The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AST = Aspartate aminotransferase, ALT = Alanine aminotransferase. |
| Secondary | Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for change in Absolute CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. |
| Secondary | Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for percent change in CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. |
| Secondary | Mean Change in Total Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL. |
| Secondary | Mean Percent Change in Total Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for percent change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. |
| Secondary | Mean Change in Platelet Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for change in Platelet Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants (units of measurement = x10\^9 cells/L). |
| Secondary | Mean Percent Change in Platelet Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | All treated participants were monitored for percent change in Platelet Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants. |
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/NCT01866930/registered