NCT07662525

Brief Summary

This is a prospective, single-arm, open-lable, single-center study and we aimed to determine whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim could induce sustained response off-treatment (SRoT) in adult patients with ITP following CS failure.

Trial Health

63
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Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
29mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Dec 2028

First Submitted

Initial submission to the registry

May 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

May 16, 2026

Last Update Submit

June 19, 2026

Conditions

Immune Thrombocytopenic Purpura

Keywords

immune thrombocytopeniaatorvastatinN-acetyl-L-cysteineromiplostimsustained response off-treatment

Outcome Measures

Primary Outcomes (1)

  • 24-week SRoT rate

    Sustained response off-treatment (SRoT) rate is defined as the proportion of patients who maintain a platelet count ≥30×10\^9/L and at least a two-fold increase from the baseline count without active bleeding following treatment discontinuation.

    24 weeks post-treatment cessation

Secondary Outcomes (7)

  • 24-week SCRoT rate

    24 weeks after treatment discontinuation

  • ORR

    Up to the end of week 24

  • CR rate

    Up to the end of week 24

  • TTR

    Up to the end of week 24

  • Sustained response

    Up to the end of week 24

  • +2 more secondary outcomes

Study Arms (1)

combined therapy

EXPERIMENTAL

atorvastatin 20mg qd , N-acetyl-L-cysteine (NAC) 400mg tid, and romiplostim

Drug: atorvastatin, NAC, and romiplostim

Interventions

atorvastatin, NAC, and romiplostimDRUG

From Week 1 to Week 24, atorvastatin and NAC was administrated as the dose of 20mg qd and 400mg tid,respectively, and were discontinued at the end of Week 24. For romiplostim, the initial dose was 3 μg/kg per week. The weekly dose was adjusted based on platelet counts, with a maximum dose of 10 μg/kg per week, to maintain platelet levels within the range of 100-200×10⁹/L during the initial 24-week period. From Week 25 to Week 35, romiplostim was gradually tapered and discontinued with the goal of maintaining a platelet count ≥30×10⁹/L and no less than twice the baseline level. After all medications (including atorvastatin, NAC, and romiplostim) were discontinued (no later than Week 36), patients were followed up for an additional 24 weeks to evaluate the sustained response rate at 24 weeks post-treatment cessation.

combined therapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with primary ITP;
  • Aged ≥18 years;
  • Patients with treatment failure or relapse after first-line corticosteriod therapy for ITP;
  • Platelet count \<30×10⁹/L.

You may not qualify if:

  • Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;
  • Presence of active malignant tumors;
  • Active HBV, HCV or HIV infection;
  • Active infection requiring systematic treatment;
  • Leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis or other hematological disorders that may cause thrombocytopenia;
  • History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure;
  • AST \> 2 times the upper limit of normal (ULN), ALT \> 2×ULN, or TBIL ≥ 1.5×ULN;
  • eGFR \< 50 mL/min/1.73m²;
  • Any other subjects deemed ineligible for enrollment by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Atorvastatinromiplostim

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 AcidsLipids

Central Study Contacts

Fu Haixia, Dr.

CONTACT

+861088326002fuhaixia_210@163.com

Xiaohui Zhang, Dr.

CONTACT

861088326001zhangxh@bjmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

May 16, 2026

First Posted

June 23, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2028

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)