Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03656068 · ClinicalTrials.gov registry record · Phase 2
An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis
A Phase 2 study of Nonalcoholic Steatohepatitis and Fatty Liver, sponsored by Pinnacle Clinical Research, P.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03656068: Completed Phase 2 study of Nonalcoholic Steatohepatitis and Fatty Liver, sponsored by Pinnacle Clinical Research, P.
NCT03656068 is a Phase 2 study of Nonalcoholic Steatohepatitis and Fatty Liver that has completed, run by Pinnacle Clinical Research, P. The registered enrollment target is 21 participants, below the 702-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03656068, a Phase 2 study of Nonalcoholic Steatohepatitis and Fatty Liver, has completed, sponsored by Pinnacle Clinical Research, P.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis
Primary Outcome
To assess the safety and tolerability of NTZ after 24 weeks of treatment by assessing the occurrence of treatment-emergent adverse events (TEAEs).
Conditions Studied
Interventions
- DRUG Nitazoxanide 500mg BID
Study Locations (1)
Texas
- Pinnacle Clinical Research - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-12-04 |
| Est. Completion | 2020-11-25 |
| Phase | Phase 2 |
What the finished NCT03656068 record still lists
NCT03656068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 702-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 1 intervention - of which Nitazoxanide 500mg BID is the first listed.
NCT03656068 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03656068 about?
NCT03656068 is a clinical study titled "An Evaluation of the Safety and Efficacy of Nitazoxanide on Collagen Turnover in NASH Patients With Fibrosis". To evaluate the safety and tolerability of Nitazoxanide (NTZ) 500mg Twice Daily (BID) after 24 weeks of treatment in patients with NASH induced Stage 2 or Stage 3 fibrosis
What is the current status of trial NCT03656068?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-12-04. Estimated completion is 2020-11-25.
What conditions does trial NCT03656068 study?
This clinical trial studies the following conditions: Nonalcoholic Steatohepatitis, Fatty Liver, Fibrosis, Liver, Compensated Cirrhosis.
What interventions are being tested in trial NCT03656068?
The interventions under investigation include: Nitazoxanide 500mg BID (DRUG).
Who is sponsoring clinical trial NCT03656068?
This trial is sponsored by Pinnacle Clinical Research, P, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03656068 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nonalcoholic Steatohepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03656068's enrollment target sits among peer trials
21 29th of 30 higher than 1 of 30 other Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Low-Dose Pioglitazone in Patients With NASH (AIM 2)
RECRUITING · Phase 2
-
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
RECRUITING · Phase 2
-
Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)
RECRUITING · Phase 2
-
A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
ACTIVE NOT RECRUITING · Phase 2
-
Role of Lisinopril in Preventing the Progression of Non-Alcoholic Fatty Liver Disease, RELIEF-NAFLD Study
ACTIVE NOT RECRUITING · Phase 2
-
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02447874 · 21 participants · Phase 1
Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
- NCT03826992 · 21 participants · Phase 1
Venetoclax Combined With Vyxeos (CPX-351) for Participants With Relapsed or Refractory Acute Leukemia
- NCT04107077 · 21 participants · Phase 2
Phase II Study of the Effects of Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Patients With Advanced Gastric Cancer
- NCT04158635 · 21 participants · Phase 1
Gemcitabine, Nab-Paclitaxel, and Bosentan for the Treatment of Unresectable Pancreatic Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI