- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01730755
Ruxolitinib for Chuvash Polycythemia
May 7, 2018 updated by: Washington University School of Medicine
Chuvash polycythemia (CP) is a rare form of congenital polycythemia caused by mutations in the VHL gene.
Currently, there are no therapies that have proven effective for CP.
Recent studies have demonstrated that VHL (von Hippel-Lindau tumor suppressor) regulates the activity of JAK2 (Janus kinase 2).
In mouse models, inhibition of JAK2 reverses the CP phenotype.
Therefore, the investigators hypothesize that JAK2 inhibition may have significant clinical benefits for CP patients.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Detailed Description
Study involvement will last for 48 weeks. There will be approximately 11 visits through week 48. Visits may take up to 2-3 hours to complete and occur every 4 weeks for the first 24 weeks, then every 12 weeks until week 48.
During each study visit, any or all of the following procedures may occur:
- List current medications and participant general health
- Obtain blood pressure, body weight, body temperature, respiratory rate and heart rate
- Measure Spleen by examination
- Obtain an abdominal MRI to evaluate spleen and any pre-existing or new blood clots
- Obtain blood samples for safety tests and to monitor kidney/liver function.
- Questionnaires for participant to complete regarding symptoms related to disease.
- Ruxolitinib dosing may be increased after 4 weeks if needed. The dose of the ruxolitinib may be reduced related to side effects.
Study Type
Expanded Access
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of Chuvash polycythemia
Exclusion Criteria:
- Unable to comprehend or unwilling to sign an informed consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 7, 2012
First Submitted That Met QC Criteria
November 15, 2012
First Posted (Estimate)
November 21, 2012
Study Record Updates
Last Update Posted (Actual)
May 14, 2018
Last Update Submitted That Met QC Criteria
May 7, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- I-RUX-12-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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