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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02134717 |
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Date of registration:
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30/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Chemokine Receptor 5 (CCR5) Inhibition on Sarcoidosis Immunophenotypes
GRADS |
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Scientific title:
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An Interventional Study of the Effect of CCR5 Inhibition With Maraviroc on Immune Cells in the the Lung and in Peripheral Blood of Patients With Sarcoidosis |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02134717 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Kevin F Gibson, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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DorothyP. and Richard P. SImmons Center for Interstitial Lung Disease at the University of Pittsburgh |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Histologically proven sarcoidosis from any site (noncaseating granulomas without other
causes).
2. Diagnosis of active sarcoidosis (Sec. 5.5.4.t) clinical stage II by Chest X-ray (CXR).
3. Forced Vital Capacity (FVC) >45% and Diffusing Capacity for Carbon Monoxide (DLCO)
>50% of predicted values.
4. Evidence of active sarcoidosis (see criteria above)
5. Able and willing to complete all study procedures (e.g., bronchoscopy, post-drug
surveillance)
6. Age: 18+ years old (prevalence greatest in young adults; pediatric maraviroc safety
not established).
7. Not on immunosuppression for sarcoidosis at the time of recruitment, (e.g., steroids,
tumor necrosis factor alpha (TNF-a) blockade)
8. Liver function (transaminases, bilirubin), coagulation (International Normalized Ratio
(INR), partial thromboplastin time (PTT), platelet count), blood urea nitrogen (BUN),
creatinine, and white blood count (WBC) within normal limits.
9. If female: negative pregnancy test, agreement to use reliable contraception if of
childbearing potential 30 days prior and for 30 days after study completion (drug
safety during pregnancy not established).
10. Negative HIV and HBsAg tests
Exclusion Criteria:
1. Diagnosis of infection based upon clinical evaluation and/or microbial testing.
2. The diagnosis of any disease involving the heart, lungs, liver (HVC), kidney,
hematologic, endocrine, or Gl systems which, in the judgment of the PI, would pose an
undue risk to the subject if they participated in this study. This includes but is not
limited to diabetes, uncontrolled hypertension, liver disease (HVC), or history of
malignancy.
3. Medications that will either inhibit or induce CYP3A4 (including St John's Wort)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sarcoidosis
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Intervention(s)
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Procedure: Bronchoscopy with bronchoalveolar lavage
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Procedure: Skin biopsy
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Drug: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks
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Procedure: venipunctures
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Primary Outcome(s)
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Total Cell Count and Differentials in Blood and Bronchoalveolar Lavage Fluid Pre- and Post Maraviroc
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Chemokine Receptor 5 (CCR5) Expression Among These Immune Effector Cells
[Time Frame: 6 weeks]
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Mononuclear Cell (MNC) Activation and T-cell Differentiation
[Time Frame: 6 weeks]
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Secondary ID(s)
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U01HL112711
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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