The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP

The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial

Sponsors

Lead Sponsor: Peking University People's Hospital

Source Peking University People's Hospital
Brief Summary

A single-arm, open-label study to evaluate the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia (ITP).

Detailed Description

This is a prospective, open-label, Phase II, single-arm interventional trial performed in a single center in China. The investigators explore the efficacy and safety of Acetylcysteine plus high-dose Dexamethasone in adults newly diagnosed with primary immune thrombocytopenia.

Overall Status Recruiting
Start Date April 1, 2019
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of patients with durable response after 6 months 6 months
Secondary Outcome
Measure Time Frame
Early response 7 days
Initial response 1 month
Bleeding 1 year
DOR 1 year
Relapse 1 year
Adverse events 1 year
Enrollment 44
Condition
Intervention

Intervention Type: Drug

Intervention Name: Dexamethasone

Description: Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated on days 11 to 14 in the case of lack of response by day 10)

Arm Group Label: High-dose Dexamethasone plus Acetylcysteine

Intervention Type: Drug

Intervention Name: Acetylcysteine

Description: Acetylcysteine, po, 400mg tid, for 4 weeks

Arm Group Label: High-dose Dexamethasone plus Acetylcysteine

Other Name: YiWeiShi

Eligibility

Criteria:

Inclusion Criteria: 1. Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed 2. Platelet count less than 30×10^9/L on two occasions or Platelets above 30×10^9/L combined with bleeding manifestation (WHO bleeding scale 2 or above) 3. Subject is ≥ 18 years and ≤80years 4. Subject has signed and dated written informed consent. 5. Fertile patients must use effective contraception during treatment and observational period 6. Negative pregnancy test Exclusion Criteria: 1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL 2. Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit of normal 3. Have a New York Heart Classification III or IV heart disease 4. Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures 5. Have active hepatitis B or hepatitis C infection 6. Have a HIV infection 7. Have active infection requiring antibiotic therapy within 7 days prior to study entry 8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug 9. Previous treatment with rituximab 10. Previous splenectomy 11. Had previous or concomitant malignant disease 12. Not willing to participate in the study. 13. Expected survival of < 2 years 14. Intolerant to murine antibodies 15. Immunosuppressive treatment within the last month 16. Connective tissue disease 17. Autoimmune hemolytic anemia 18. Patients currently involved in another clinical trial with evaluation of drug treatment

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Xiaohui Zhang, MD Principal Investigator Peking University People's Hospital, Peking University Insititute of Hematology
Overall Contact

Last Name: Xiaohui Zhang, MD

Phone: +8613522338836

Email: [email protected]

Location
Facility: Status: Contact: Peking University Insititute of Hematology, Peking University People's Hospital Xiaohui Zhang, MD +8613522338836 [email protected]
Location Countries

China

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Peking University People's Hospital

Investigator Full Name: Xiao Hui Zhang

Investigator Title: Vice president of Peking University Institute of Hematology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: High-dose Dexamethasone plus Acetylcysteine

Type: Experimental

Description: For all patients in this arm, DXM was administered intravenously at 40 mg daily for 4 consecutive days and then stopped. If platelet count remained below 30×10^9/L or there were bleeding symptoms by day 10 to 14, an additional 4-day course of DXM (40 mg daily) was given. Besides, all patients received Acetylcysteine orally at 0.4g three times a day for 4 consecutive weeks in the first month.

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov