An Early Phase 1 interventional study of Hydroxychloroquine in Liver Cirrhosis and Muscle Cramps, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Supportive care
Among 231 studies in Liver Cirrhosis with a site in United States — 45 open to participants now, 63 under way, 3 of them phase 3. Liver Cirrhosis · United States.
Among the 231 studies in Liver Cirrhosis with a site in United States, this one is the 159th largest by enrollment of the 166 interventional ones, is one of 5 that started in 2011, is one of 26 in phase 1, and was the 35th registered.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 3 is below the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →45 of the 231 studies in Liver Cirrhosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 208 Liver Cirrhosis studies recruiting now, 101 (49%) set no upper age limit and 66 (32%) stop at 75 or younger; 12 take children under 18; 25 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →231 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 5 started in 2011.
Median enrollment 55 across the 166 interventional studies, 109 across the 63 observational. Of the 150 that completed or were terminated, 63 (42%) have results posted.
85 of 231 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 4 studies filed under Liver Cirrhosis — fewer than ten, so there is no comparison to draw.
24 of the studies in Liver Cirrhosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05500222Phase 3Madrigal Pharmaceuticals, Inc.A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) | 2026-12 |
| NCT04592744University of California, Los AngelesAngiotensin 2 for AKI After OLT | 2026-12 |
| NCT03973372University of Texas Southwestern Medical CenterALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement | 2026-12 |
| NCT05998330Massachusetts General HospitalLiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease | 2026-12-01 |
| NCT04820036Brigham and Women's HospitalA Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG) | 2026-12-24 |
Among the 231 studies in Liver Cirrhosis with a site in United States, from their registry updates:
This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.
This project is proposed as a pilot study to gather preliminary data for a full-scale randomized trial to assess the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of muscle cramps in patients with cirrhosis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Hydroxychloroquine
daily dosing
Also known as: Plaquenil
frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)
Patients will be given the mMCQ and SF-12 to complete. These instruments will be scored according to established algorithms. Data analysis will include descriptive statistics (frequency, duration and severity of muscle cramps) and correlation between overall quality of life and the mMCQ summary score.
Time frame: 1 month after completion of questionnaire
safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.
The study intervention will include open label HCQ daily, which will be provided for the patients for two weeks. A designated coordinator will contact the patient 2 and 7 days of the study to ask of adverse events and fill out the AE inventory. At the end of the dosing, patients will be asked to return to the clinic for post-intervention assessment, which will include the mMCQ, SF-12, systemic AE inventory, CBC and EKG. Designated coordinator will contact patient again on day 28 of the study to ask mMCQ, SF-12, AE inventory.
Time frame: 28 days after first dose
The record gives a start of Dec 2011, a primary completion of Apr 2015 and a completion of Apr 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxychloroquine