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NCT01369212 · ClinicalTrials.gov registry record · Phase 3
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
NCT01369212 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 201 participants.
The verdict
NCT01369212, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
Study Summary
This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained off-treatment response).
Interventions
- DRUG Tenofovir
- DRUG Peginterferon-alfa 2a and tenofovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2012-11 |
| Est. Completion | 2021-03-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369212
The ClinicalTrials.gov registry entry for NCT01369212 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 201 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tenofovir is the first listed.
NCT01369212 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01369212 about?
NCT01369212 is a clinical study titled "Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B". This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum ...
What is the current status of trial NCT01369212?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2012-11. Estimated completion is 2021-03-08.
What interventions are being tested in trial NCT01369212?
The interventions under investigation include: Tenofovir (DRUG), Peginterferon-alfa 2a and tenofovir (DRUG).
Who is sponsoring clinical trial NCT01369212?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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