NCT03528070

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2018

Typical duration for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 17, 2018

Status Verified

January 1, 2018

Enrollment Period

2 years

First QC Date

April 19, 2018

Last Update Submit

May 6, 2018

Conditions

Sarcoidosis

Keywords

SarcoidosisTranilastskinlung

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 months

  • 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.

    12 months

Study Arms (1)

Tranilast

EXPERIMENTAL
Drug: Tranilast

Interventions

TranilastDRUG

Subjects will be treated with tranilast

Tranilast

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • )with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcoidosis

Interventions

tranilast

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Central Study Contacts

Maihua Hou, professor

CONTACT

+86 13776635881houmaihua@jsph.org.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 17, 2018

Study Start

May 1, 2018

Primary Completion

May 1, 2020

Study Completion

December 1, 2020

Last Updated

May 17, 2018

Record last verified: 2018-01