Back to resultsThe Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP
Primary Purpose
Immune Thrombocytopenia
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
Acetylcysteine
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring immune thrombocytopenia, acetylcysteine
Eligibility Criteria
Inclusion Criteria:
- Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
- 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)
- Subject is ≥ 18 years and ≤80years
- Subject has signed and dated written informed consent.
- Fertile patients must use effective contraception during treatment and observational period
- Negative pregnancy test
Exclusion Criteria:
- Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
- 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
- Have a New York Heart Classification III or IV heart disease
- Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
- Have active hepatitis B or hepatitis C infection
- Have a HIV infection
- Have active infection requiring antibiotic therapy within 7 days prior to study entry
- Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
- Previous treatment with rituximab
- Previous splenectomy
- Had previous or concomitant malignant disease
- Not willing to participate in the study.
- Expected survival of < 2 years
- Intolerant to murine antibodies
- Immunosuppressive treatment within the last month
- Connective tissue disease
- Autoimmune hemolytic anemia
- Patients currently involved in another clinical trial with evaluation of drug treatment
Sites / Locations
- Peking University Insititute of Hematology, Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High-dose Dexamethasone plus Acetylcysteine
Arm 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.
Outcomes
Primary Outcome Measures
Number of patients with durable response after 6 months
Number of patients with durable response after 6 months
Secondary Outcome Measures
Early response
Number of patients with early response on day 7
Initial response
Number of patients with initial response at 1 month
Bleeding
Number of patients with bleeding complication therapy; bleeding score
DOR
duration of response
Relapse
Number of patients relapse during the observation
Adverse events
Number of patients with adverse events
Full Information
NCT ID
NCT04368598
First Posted
April 26, 2020
Last Updated
April 28, 2020
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04368598
Brief Title
The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP
Official Title
The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
immune thrombocytopenia, acetylcysteine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-dose Dexamethasone plus Acetylcysteine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
HD-DXM, High-dose Dexamethasone
Intervention 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)
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine
Other Intervention Name(s)
YiWeiShi
Intervention Description
Acetylcysteine, po, 400mg tid, for 4 weeks
Primary Outcome Measure Information:
Title
Number of patients with durable response after 6 months
Description
Number of patients with durable response after 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Early response
Description
Number of patients with early response on day 7
Time Frame
7 days
Title
Initial response
Description
Number of patients with initial response at 1 month
Time Frame
1 month
Title
Bleeding
Description
Number of patients with bleeding complication therapy; bleeding score
Time Frame
1 year
Title
DOR
Description
duration of response
Time Frame
1 year
Title
Relapse
Description
Number of patients relapse during the observation
Time Frame
1 year
Title
Adverse events
Description
Number of patients with adverse events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically confirmed immune thrombocytopenic purpura (ITP) newly diagnosed
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)
Subject is ≥ 18 years and ≤80years
Subject has signed and dated written informed consent.
Fertile patients must use effective contraception during treatment and observational period
Negative pregnancy test
Exclusion Criteria:
Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
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
Have a New York Heart Classification III or IV heart disease
Have a history of severe psychiatric disorder or are unable to comply with study and follow-up procedures
Have active hepatitis B or hepatitis C infection
Have a HIV infection
Have active infection requiring antibiotic therapy within 7 days prior to study entry
Are pregnant or lactating women, or plan to become pregnant or impregnated within 12 months of receiving study drug
Previous treatment with rituximab
Previous splenectomy
Had previous or concomitant malignant disease
Not willing to participate in the study.
Expected survival of < 2 years
Intolerant to murine antibodies
Immunosuppressive treatment within the last month
Connective tissue disease
Autoimmune hemolytic anemia
Patients currently involved in another clinical trial with evaluation of drug treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohui Zhang, MD
Phone
+8613522338836
Email
zhangxh100@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinglin Wang, MD
Phone
+8613051522865
Email
wxlbjmu@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui Zhang, MD
Organizational Affiliation
Peking University People's Hospital, Peking University Insititute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Insititute of Hematology, Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaohui Zhang, MD
Phone
+8613522338836
Email
zhangxh100@sina.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed ITP
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