Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Acitretin Capsules

NCT ID: NCT02715960

Last Updated: 2016-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2017-12-31

Brief Summary

In an early clinical research, 138 patients completed the treatment of Psoriasis Vulgaris by Acitretin Capsules in 8 weeks, the results indicate 75 cases effectively (54.3%), 50 cases invalid(36.2%), 13 cases serious(9.4%). To investigate the influence of genetic factors on the curative effect and find the relationships between genetic variants and the response of Acitretin Capsules to treatment of Psoriasis Vulgaris.

Detailed Description

Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME affect the efficacy of Acitretin Capsules; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Acitretin Capsules.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single-arm

intervention: open registry, non-randomized, single-arm trial. Acitretin Capsules: 2.5 per piece.

Group Type: EXPERIMENTAL

Acitretin Capsules

Intervention Type: DRUG

During The first treatment stage:10mg per day, 3 days,oral; The second stage: 20mg per day, 3 days,oral; The third stage: 30mg per day, and maintain this dose,oral.

Interventions

Acitretin Capsules

During The first treatment stage:10mg per day, 3 days,oral; The second stage: 20mg per day, 3 days,oral; The third stage: 30mg per day, and maintain this dose,oral.

Intervention Type: DRUG

Other Intervention Names

Tretinoin, Vitamine A Acid

Eligibility Criteria

Inclusion Criteria

1. Diagnosed according to Classification criteria for Psoriasis vulgaris

2. Patients aged 18 to 70 years (to the date of screening)

3. PASI grade ≥7point

4. Not treatment in the Topical corticosteroids, Immunosuppression, Biologicals agents or Tretinoin cream, Phototherapy nearly one months before enrolled.

5. Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN if not liver metastases<5 x ULN if known liver metastases, Creatinine clearance <1.5 x ULN

6. Understanding the whole process of the study, voluntary participation and signed the informed consent

Exclusion Criteria

1. Pregnant women, ready to pregnant or lactating women

2. Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history

3. Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers

4. Patients with chronic diarrhea, or peptic ulcer nearly 1 year

5. Patients suffering from malignant tumor

6. Patients suffering from acute and chronic infectious diseases

7. Mental disorders, history of alcohol abuse, drug or other substance abuse

8. Other cases which researchers believe that can not enroll

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Yijing He

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Xiangya Hospital of Central South University

Locations

Xiangya Hospital Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yijing He, PhD,MD

Role: CONTACT

yijinghe@gmail.com

+86-1587481262

Facility Contacts

Yijing He, MD, PhD

Role: primary

yijinghe@gmail.com

+86-1587481262

Other Identifiers

2016 AW/CSU/PS

Identifier Type: -

Identifier Source: org_study_id