The Combination of High-dose Dexamethasone and Acetylcyst... | NCT04368598

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

NCT04368598

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Apr 30, 2020Actual

Enrollment

44Estimated

Phase

Phase 2

Conditions

Immune Thrombocytopenia

Interventions

Dexamethasone
Acetylcysteine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2019Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Apr 26, 2020

First Submission Date that Met QC Criteria

Apr 28, 2020

First Posted Date

Apr 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2020

Last Update Posted Date

Apr 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High-dose Dexamethasone plus Acetylcysteine	Experimental	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.	Drug: Dexamethasone Drug: Acetylcysteine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	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)	High-dose Dexamethasone plus Acetylcysteine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with durable response after 6 months	Number of patients with durable response after 6 months	6 months

Secondary Outcomes

Measure	Description	Time Frame
Early response	Number of patients with early response on day 7	7 days
Initial response	Number of patients with initial response at 1 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaohui Zhang, MD	Contact	+8613522338836		zhangxh100@sina.com
Xinglin Wang, MD	Contact	+8613051522865		wxlbjmu@163.com

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Insititute of Hematology, Peking University People's Hospital	Recruiting	Beijing	Beijing Municipality	100044	China

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids