NCT03460808

Brief Summary

Single-arm, open-lable, multicentre study to compare the efficacy and safety of atorvastatin, acetylcysteine plus danazol with danazol monotherapy in patients with corticosteroidresistant/relapsed ITP.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

March 10, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 9, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

March 5, 2018

Last Update Submit

March 5, 2018

Conditions

Immune Thrombocytopenia

Keywords

steroid-resistantrefractoryAtorvastatinAcetylcysteineDanazol

Outcome Measures

Primary Outcomes (1)

  • the sustained platelet response at the 6-month follow-up

    The number of participants (responders) with platelet count \>=30x10\^9/L and at least a 2-fold increase in the baseline count (PR) or a platelet count \>=100x10\^9/L (CR) and the absence of bleeding, without rescue medication at 6-month follow-up.

    From the start of study treatment (Day 1) up to the end of Month 6

Secondary Outcomes (4)

  • overall response

    From the start of study treatment (Day 1) up to the end of Month 6

  • time to response

    From the start of study treatment (Day 1) up to the end of Year 2

  • duration of response

    From the start of study treatment (Day 1) up to the end of Year 2

  • incidence of treatment-emergent adverse events

    From the start of study treatment (Day 1) up to the end of Year 2

Study Arms (1)

atorvastatin, acetylcysteine & danazol

EXPERIMENTAL

atorvastatin 20mg qd po plus acetylcysteine 400mg tid po plus danazol 200mg bid po for 12 weeks

Drug: atorvastatinDrug: AcetylcysteineDrug: Danazol

Interventions

atorvastatinDRUG

Atorvastatin was used in combination with acetylcysteine and danazol.

atorvastatin, acetylcysteine & danazol
AcetylcysteineDRUG

Acetylcysteine was used in combination with atorvastatin and danazol.

atorvastatin, acetylcysteine & danazol
DanazolDRUG

Danazol was used in combination with atorvastatin and acetylcysteine or as the monotherapy

Also known as: Danocrine, Cleregil, Danol
atorvastatin, acetylcysteine & danazol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ITP confirmed by excluding other supervened causes of thrombocytopenia;
  • Platelet count of less than 30×10\^9/L at enrollment;
  • Patients who did not achieve a sustained response to treatment with full dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;
  • ECOG\<2.
  • EPCs in bone marrow less than 0.02%

You may not qualify if:

  • Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)
  • congestive heart failure
  • severe arrhythmia
  • nursing or pregnant women
  • aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria
  • creatinine or serum bilirubin levels each 1.5 times or more than the normal range
  • active or previous malignancy
  • Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

AtorvastatinAcetylcysteineDanazoldeanol aceglutamate

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsCysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Xiao-hui Zhang, Professor

CONTACT

+86 010-88324516zhangxh100@sina.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2018

First Posted

March 9, 2018

Study Start

March 10, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2023

Last Updated

March 9, 2018

Record last verified: 2018-03

Locations

CN(1)