Trial · NCT00516321
Outcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Intent-to-Treat (ITT) Population: all participants randomized in the DB Phase | participants | NUMBER |
| SECONDARY | Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 90 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase | From Baseline up to Week 9 in the OL Phase | Safety Population: all participants who had received study drug in the OL Phase | participants | NUMBER |
| SECONDARY | Number of Participants Receiving the Indicated Doses of Eltrombopag in the OL Phase Who Initiated Antiviral Therapy (Peginterferon Alfa-2a and Ribavirin) in the DB Phase | From Baseline up to Week 9 in the OL Phase | Safety Population. Participants with a platelet count \>=90 Gi/L and who initiated antiviral therapy during the DB Phase were analyzed. | participants | NUMBER |
| SECONDARY | Median Platelet Count at the Indicated Time Points During the OL Phase | OL Phase: Baseline; Day 1; Weeks 1, 2, 3, 4, 5, 6, 7, 8, and 9; Antiviral Baseline (up to Week 10); End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 62); 12-week FU (up to Week 70); and 24-week FU (up to Week 82) | Safety Population. Only those participants contributing data at the indicated time points were analyzed. | Gi/L | MEDIAN |
| SECONDARY | Median Platelet Count at the Indicated Time Points During the DB Phase | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) | ITT Population. Only those participants contributing data at the indicated time points were analyzed. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. | Gi/L | MEDIAN |
| SECONDARY | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) During the DB Phase | From Baseline up to Week 12 | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) During the DB Phase | From Baseline up to Week 12 | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With End of Treatment Response (ETR) and Sustained Virological Response at Week 12 of Follow-up (SVR12) During the DB Phase | From Baseline up to Week 36 or Week 60 (for participants with Genotype 2/3) or up to Week 60 (for participants with Non-Genotype 2/3) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants in the Indicated Categories for Antiviral Therapy Dose Reductions in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | ITT Population | participants | NUMBER |
| SECONDARY | Time to First Dose Reduction of Peginterferon Alfa-2a and Ribavirin Therapy in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | ITT Population. Only those participants with dose reductions were analyzed. | weeks | MEAN |
| SECONDARY | Number of Participants With the Indicated Levels of Peginterferon Dose Reductions in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | ITT Population. One participant could have had more than one dose reduction. | participants | NUMBER |
| SECONDARY | Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants (Par.) Categorized as Responders (R) and Non-responders (NR) for SVR and RVR to Antiviral Therapy in the Indicated Variants of Interleukin 28B (IL28B) (or Interferon, Lambda 3) During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Pharmacogenetic (PGx) Sub-Population: participants enrolled in this study who provided written informed consent for PGx research with a blood sample for genotyping and who were successfully genotyped for at least one of the two genetic markers under study | participants | NUMBER |
| SECONDARY | Number of Par. With the Indicated Shift From Baseline (BL) in Severity Grades for Clinical Chemistry Parameters (Calcium, Glucose [Glu.], Potassium [Pot.], and Sodium [Sod.]), Per Division of Acquired Immunodeficiency Syndrome (DAIDS) During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Safety DB Population: all randomized participants who had received study drug in the DB Phase | participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Shifts From BL in Severity Grades for for Hematology Parameters (Hemoglobin, Lymphocytes [Lym.], Total Neutrophils [Tot Neu.], and White Blood Cells [WBC]), Per DAIDS During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Safety DB Population | participants | NUMBER |
| SECONDARY | Number of Participants in the Indicated Categories for Cataract Event During the DB Phase, Per Clinical Events Committee (CEC) Adjudication During the DB Phase | From Baseline up to Week 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | Safety DB Population | participants | NUMBER |
| SECONDARY | Number of Participants Assessed as Normal and Abnormal (Clinically Significant [CS] and Not Clinically Significant [NCS]) for 12-lead Electrocardiogram (ECG) at the Indicated Time Points During the DB Phase | DB Phase: Antiviral BL (up to Week 10); End of Treatment (up to Week 52); and 24-week FU (up to Week 72) | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. Worst ECG post-BL is the worst ECG assessment reported for a participant at a post-BL assessment and could be Normal, Abnormal - NCS, Abnormal - CS, or Abnormal (NCS or CS not given). | participants | NUMBER |
| SECONDARY | Number of Participants With CS and NCS Change From Baseline for 12-lead ECG at the Indicated Time Points During the DB Phase | End of Treatment (up to Week 52); and 24-week FU (up to Week 72) | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. | participants | NUMBER |
| SECONDARY | Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at the Indicated Time Points During the DB Phase | DB Phase: Baseline; Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44; End of Treatment (up to Week 48); 4-week Follow-up (FU) (up to Week 52); 12-week FU (up to Week 60); and 24-week FU (up to Week 72) | Safety DB Population. Only those participants contributing data at the indicated time points were analyzed. | Millimeters of mercury (mmHg) | MEAN |
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.
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