CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
Ribavirin +1 moredrug
Likely dose
Ribavirin 60 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01502072
NCT01502072Phase 2Completed
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An Open Label Randomized Controlled Trial To Prevent the Progression of Respiratory Syncytial Virus Upper Respiratory Tract Infection to Lower Respiratory Tract Infection in Patients After Hematopoietic Stem Cell Transplant

M.D. Anderson Cancer Center·interventional·Posted Dec 30, 2011·Updated Feb 15, 2021

In Brief

A Phase 2 clinical trial evaluating Ribavirin for Bone Marrow Transplant Infection and 5 related conditions. Completed, enrolled 48 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if ribavirin can help to control RSV in patients with immune systems that have been weakened by a stem cell transplant. Researchers also want to compare the effectiveness of the drug when it is given by mouth to when it is inhaled. The safety of the drug in both methods of delivery will be studied. Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Marrow Transplant Infection, Infection in Marrow Transplant Recipients, Respiratory Syncytial Virus Infections, Respiratory Syncytial Virus Pneumonia, Cancer, Acute Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2011
Enrollment StartDec 28, 2011
Primary CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 14.5 years ago

Interventions

Ribavirindrug

Modified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask.

Ribavirindrug

One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).