Thrombocytopenia in Gestational Period

NCT02751593 | Unknown Phase 2 DMC

• 1 other identifier: pregnancy and thrombocytopenia
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.

Conditions

Immune Thrombocytopenia; Pregnancy

Keywords

pregnancy; Immune Thrombocytopenia; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Response rate (CR+R)

  3 months

Secondary Outcomes (3)

• Platelet count

  2 years

• Adverse events

  2 years

• live birth rate

  2 years

Study Arms (1)

dexamethasone

EXPERIMENTAL

dexamethasone 40mg/d for 4 days

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

dexamethasone 40mg/d for 4 days

dexamethasone

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is between 20-50 years old.
• After 12 weeks gestation.
• Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
• Patients who have no response or relapsed after Corticosteroid or IVIG.
• Patients developed refractoriness to platelet transfusion.
• To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
• 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 second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
• 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).
• 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

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Dexamethasone

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Xiao-hui Zhang, Dr

  Peking University People's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2016
• First Posted: April 26, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 26, 2016

Record last verified: 2016-04