Trial · NCT00529568
Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease
NCT00529568, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease. Trials, record NCT00529568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00529568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Eltrombopag To Initiate And Maintain Interferon Antiviral Treatment To Benefit Subjects With Hepatitis C Liver Disease
- NCT number
- NCT00529568
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 759 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hepatitis C, Chronic
- Interventions
- eltrombopag, placebo
- First posted
- 2007-09-14
- Last updated
- 2013-11-05
- Results first posted
- 2012-05-17
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | Participants with SVR are defined as those with non-detectable Hepatitis C Virus (HCV) ribonucleic acid (RNA) at the end of treatment and all subsequent planned visits up to 24 weeks post-completion of the treatment period of the DB Phase. |
| Secondary | Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 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 | Participants were assessed for a shift from a baseline platelet count of \<75 Gi/L to a count \>=100 Gi/L during the OL Phase (up to 9 weeks). Local laboratories were used for platelet function tests. Platelet counts were measured by blood draw. |
| 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 | In the OL Phase, participants initially received the lowest dose of eltrombopag (25 mg QD) for 2 weeks. If after this time the platelet count was \<100 Gi/L, participants underwent sequential dose escalation to the next highest dose (50 mg QD for up to 2 weeks), with further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) if platelet counts remained \<100 Gi/L. Participants who achieved platelet counts \>=100 Gi/L when receiving any of the eltrombopag doses in the OL Phase initiated antiviral therapy in the DB Phase. |
| 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) | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. |
| 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) | Blood taken from peripheral blood vessels was used for the measurement of platelet counts. The Last On Treatment assessment refers to the actual last treatment assessment, not necessarily to the End of Treatment assessment entered by the Investigator. |
| Secondary | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | 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) | The minimum platelet count with antiviral therapy was categorized as follows: \<25 Gi/L; \>=25 to \<50 Gi/L; \>=50 to \<90 Gi/L; \>=90 to \<150 Gi/L; \>=150 Gi/L to \<200 Gi/L; \>=200 Gi/L to \<400 Gi/L; and \>=400 Gi/L. |
| Secondary | Number of Participants With Rapid Virological Response (RVR) and Extended RVR (eRVR) 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) | RVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment. eRVR is defined as the absence of detectable HCV RNA after 4 weeks of antiviral treatment that persisted through Week 12. |
| Secondary | Number of Participants With Early Virological Response (EVR) and Complete EVR (cEVR) 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) | EVR is defined as a clinically significant reduction from Baseline in HCV RNA (\>=2 log10 drop or undetectable) after 12 weeks of antiviral treatment. cEVR is defined as undetectable HCV RNA after 12 weeks of antiviral treatment. |
| 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 48 or Week 72 (for participants with Genotype 2/3) or up to Week 72 (for participants with Non-Genotype 2/3) | ETR is defined as the absence of detectable HCV RNA at the end of antiviral treatment. SVR12 is defined as the absence of detectable HCV RNA at the end of antiviral treatment and the 12-week follow-up assessment. |
| 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) | Participants were assigned a score equal to the number of times their dose of antiviral therapy (peginterferon or ribavirin) was reduced (0=no dose reductions \[DRs\]; 1=one DR; 2=two DRs; 3=three DRs; \>3=more than three DRs). When possible, every effort was made to maintain the recommended dose of antiviral therapy for the treatment duration in the DB Phase. However, when dose modification of antiviral therapy was required due to safety concerns, it was performed by the Investigator as per the region-specific product labels of peginterferon and ribavirin. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 (>=) 100 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 \>=100 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. | Gi/L | MEDIAN |
| SECONDARY | Number of Participants in the Indicated Categories for Minimum Platelet Count With Antiviral Therapy | 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 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 Early Virological Response (EVR) and Complete EVR (cEVR) 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 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 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 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 |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group514
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | Placebo+Antiviral Therapy: DB Phase | 32 | participants | ||
| Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | Eltrombopag+Antiviral Therapy: DB Phase | 97 | participants | ||
Number of Participants Whose Platelet Count Increased From a Baseline Count of <75 Gi/L to a Count Greater Than or Equal to (>=) 100 Giga (10^9) Cells Per Liter (Gi/L) During the Open-label (OL) Pre-Antiviral Treatment Phase | Eltrombopag: OL Phase | 773 | participants | ||
| 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 | Eltrombopag: OL Phase | 25 mg | 443 | participants | |
| 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 | Eltrombopag: OL Phase | 50 mg | 208 | participants | |
| 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 | Eltrombopag: OL Phase | 75 mg | 77 | participants | |
| 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 | Eltrombopag: OL Phase | 100 mg | 31 | participants | |
| Median Platelet Count at the Indicated Time Points During the OL Phase | Eltrombopag: OL Phase | Baseline, n=797 | 59.0 | Full Range 12 to 95 | Gi/L |
| Median Platelet Count at the Indicated Time Points During the OL Phase | Eltrombopag: OL Phase | Day 1, n=714 | 58.0 | Full Range 5 to 117 | Gi/L |
| Median Platelet Count at the Indicated Time Points During the OL Phase | Eltrombopag: OL Phase | Week 1, n=791 | 77.0 | Full Range 5 to 223 | Gi/L |
1 to 10 of 514Source ClinicalTrials.gov
See all 514 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Pre-Antiviral Treatment Phase | STARTED | Eltrombopag: Open-label Phase | 805 | |
| Open-label Pre-Antiviral Treatment Phase | STARTED | Placebo+Antiviral Therapy: DB Phase | 0 | |
| Open-label Pre-Antiviral Treatment Phase | STARTED | Eltrombopag+Antiviral Therapy: DB Phase | 0 | |
| Open-label Pre-Antiviral Treatment Phase | COMPLETED | Eltrombopag: Open-label Phase | 759 | |
| Open-label Pre-Antiviral Treatment Phase | COMPLETED | Placebo+Antiviral Therapy: DB Phase | 0 | |
| Open-label Pre-Antiviral Treatment Phase | COMPLETED | Eltrombopag+Antiviral Therapy: DB Phase | 0 | |
| Open-label Pre-Antiviral Treatment Phase | NOT COMPLETED | Eltrombopag: Open-label Phase | 46 | |
| Open-label Pre-Antiviral Treatment Phase | NOT COMPLETED | Placebo+Antiviral Therapy: DB Phase | 0 | |
| Open-label Pre-Antiviral Treatment Phase | NOT COMPLETED | Eltrombopag+Antiviral Therapy: DB Phase | 0 | |
| Double-bilnd Antiviral Treatment Phase | STARTED | Eltrombopag: Open-label Phase | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events603
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Eltrombopag: OL Phase | 0 | 805 | |
| other | Pyrexia | General disorders | Placebo+Antiviral Therapy: DB Phase | 60 | 252 | |
| other | Pyrexia | General disorders | Eltrombopag+Antiviral Therapy: DB Phase | 141 | 506 | |
| other | Fatigue | General disorders | Eltrombopag: OL Phase | 0 | 805 | |
| other | Fatigue | General disorders | Placebo+Antiviral Therapy: DB Phase | 53 | 252 | |
| other | Fatigue | General disorders | Eltrombopag+Antiviral Therapy: DB Phase | 124 | 506 | |
| other | Influenza like illness | General disorders | Eltrombopag: OL Phase | 0 | 805 | |
| other | Influenza like illness | General disorders | Placebo+Antiviral Therapy: DB Phase | 36 | 252 | |
| other | Influenza like illness | General disorders | Eltrombopag+Antiviral Therapy: DB Phase | 100 | 506 | |
| other | Asthenia | General disorders | Eltrombopag: OL Phase | 0 | 805 |
1 to 10 of 603Source ClinicalTrials.gov
See all 603 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eltrombopag: OL Phase | ||
| Total, all-cause mortality | Placebo+Antiviral Therapy: DB Phase | ||
| Total, all-cause mortality | Eltrombopag+Antiviral Therapy: DB Phase | ||
| Total, other adverse events | Eltrombopag: OL Phase | 0 | 805 |
| Total, other adverse events | Placebo+Antiviral Therapy: DB Phase | 226 | 252 |
| Total, other adverse events | Eltrombopag+Antiviral Therapy: DB Phase | 459 | 506 |
| Total, serious adverse events | Eltrombopag: OL Phase | 9 | 805 |
| Total, serious adverse events | Placebo+Antiviral Therapy: DB Phase | 49 | 252 |
| Total, serious adverse events | Eltrombopag+Antiviral Therapy: DB Phase | 119 | 506 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Placebo+Antiviral Therapy: DB Phase vs Eltrombopag+Antiviral Therapy: DB Phase: Number of Participants Who Prematurely Discontinued Antiviral Therapy in the DB Phase | Trial comparisons |
| Placebo+Antiviral Therapy: DB Phase vs Eltrombopag+Antiviral Therapy: DB Phase: Number of Participants With Sustained Virologic Response (SVR) in the Double-blind (DB) Antiviral Treatment Phase | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00529568
GET https://conductscience.org/api/trials/v1/NCT00529568/registered?page=2