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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368598
• Other study ID #: ITP-PKU008
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2020
• Source: Peking University People's Hospital
• Contact: Xiaohui Zhang, MD
• Phone: +8613522338836
• Email: zhangxh100[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Dexamethasone
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)
• Acetylcysteine
Acetylcysteine, po, 400mg tid, for 4 weeks

Locations

Country	Name	City	State
China	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with durable response after 6 months	Number of patients with durable response after 6 months	6 months
Secondary	Early response	Number of patients with early response on day 7	7 days
Secondary	Initial response	Number of patients with initial response at 1 month	1 month
Secondary	Bleeding	Number of patients with bleeding complication therapy; bleeding score	1 year
Secondary	DOR	duration of response	1 year
Secondary	Relapse	Number of patients relapse during the observation	1 year
Secondary	Adverse events	Number of patients with adverse events	1 year