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NCT04903626 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 286
- Enrollment target
NCT04903626 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 286 participants.
The verdict
NCT04903626, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 286 participants
- Enrollment target
Study Summary
HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide. Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.
Interventions
- DRUG Glecaprevir/Pibrentasvir (GLE/PIB)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2024-09-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04903626
The ClinicalTrials.gov registry entry for NCT04903626 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 526 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Glecaprevir/Pibrentasvir (GLE/PIB) is the first listed.
NCT04903626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04903626 about?
NCT04903626 is a clinical study titled "Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)". HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection. GLE/PIB is an approved d...
What is the current status of trial NCT04903626?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 286 participants. The study started on 2021-08-24. Estimated completion is 2024-09-17.
What interventions are being tested in trial NCT04903626?
The interventions under investigation include: Glecaprevir/Pibrentasvir (GLE/PIB) (DRUG).
Who is sponsoring clinical trial NCT04903626?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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