A Study of ATRA in the Treatment of ITP

NCT04618328 | Unknown Phase 2

• 1 other identifier: 5000 offer
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label, multicenter study to compare the efficacy and safety of ATRA for the treatment of adults with primary immune thrombocytopenia (ITP)

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Sustained response

  The maintenance of platelet count ≥ 30 x 10\^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up

  6 months

Secondary Outcomes (7)

• complete response (CR)

  day 14

• Response (R)

  day 14

• Number of patients with bleeding

  6 months

• Number of patients with adverse events

  6 months

• Time to response

  6 months

Study Arms (1)

ATRA treatment group

EXPERIMENTAL

ATRA is given at a daily dose of 10 mg twice daily orally for 12 weeks

Drug: all trans retinoic acid

Interventions

all trans retinoic acid DRUG

ATRA is given concomitantly at a daily dose of 10 mg twice daily orally for 12 weeks

Also known as: ATRA

ATRA treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed newly-diagnosed, treatment-naive ITP;
• Platelet counts \<30×109/L ;
• Platelet counts \< 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
• Willing and able to sign written informed consent.

You may not qualify if:

• Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit;
• Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit;
• Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
• Current HIV infection or hepatitis B virus or hepatitis C virus infections;
• Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
• Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period;
• Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
• Patients who are deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Qilu Hospital of Shandong University: collaborator
• Beijing Hospital: collaborator
• Navy General Hospital, Beijing: collaborator

Study Sites (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Tretinoin

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vitamin A; Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Xiaohui Zhang, Doctor

  Peking University People's Hospital, Peking University Insititute of Hematology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui Zhang, Doctor

CONTACT

+8613522338836; zhangxh100@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking Univeristy Institute of Hematology

Model Details: ATRA is used to treat ITP patients.

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 5, 2020
• Study Start: November 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: November 5, 2020

Record last verified: 2020-10

Locations

CN (1)