A Clinical Study of Tranilast in the Treatment of Sarcoidosis
Primary Purpose
Sarcoidosis
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Tranilast
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoidosis focused on measuring Sarcoidosis, Tranilast, skin, lung
Eligibility Criteria
Inclusion Criteria:
- (1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic granuloma and negative staining of fungi and atypical mycobacterium; (2)No corticosteroids and immunosuppressants were used for nearly 1 months.
Exclusion Criteria:
- 1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tranilast
Arm Description
Outcomes
Primary Outcome Measures
Changes in the size of the pulmonary nodule by ultrasound
During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the size of the pulmonary nodule by ultrasound. The investigators can get the changes in the size of the pulmonary nodule.
Changes of the forced vital capacity(FVC)
During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the forced vital capacity(FVC),then get the changes.
Secondary Outcome Measures
Full Information
NCT ID
NCT03528070
First Posted
April 19, 2018
Last Updated
May 6, 2018
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03528070
Brief Title
A Clinical Study of Tranilast in the Treatment of Sarcoidosis
Official Title
A Clinical Study of Tranilast in the Treatment of Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
56 patients with sarcoidosis will be selected to receive treatment of tranilast.The investigators can analyse the changes in the thickness and area of skin lesions before and after treatment as well as other involved organs nodule size changes to determine the efficacy and safety of drugs.
Detailed Description
56 patients with sarcoidosis will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos, the size of the lump by ultrasound, the forced vital capacity(FVC), and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast treatment (0.1g each time, three times a day) , participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, every three months to retest ultrasound and the forced vital capacity(FVC). With 3 month as a time point, participants were observed for four points(one point if only skin invasion ).After the experiment, the experimental data will be arranged and the data will be statistically processed (t test) to determine whether it is meaningful.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis
Keywords
Sarcoidosis, Tranilast, skin, lung
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranilast
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tranilast
Intervention Description
Subjects will be treated with tranilast
Primary Outcome Measure Information:
Title
Changes in the size of the pulmonary nodule by ultrasound
Description
During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the size of the pulmonary nodule by ultrasound. The investigators can get the changes in the size of the pulmonary nodule.
Time Frame
12 months
Title
Changes of the forced vital capacity(FVC)
Description
During tranilast (0.1g each time, three times a day,12 months) treatment, patients need to retest the forced vital capacity(FVC),then get the changes.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic granuloma and negative staining of fungi and atypical mycobacterium; (2)No corticosteroids and immunosuppressants were used for nearly 1 months.
Exclusion Criteria:
1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maihua Hou, professor
Phone
+86 13776635881
Email
houmaihua@jsph.org.cn
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study of Tranilast in the Treatment of Sarcoidosis
We'll reach out to this number within 24 hrs