Immune Thrombocytopenic PurpuraNCT07662525
Atorvastatin Combined With NAC Plus Romiplostim for Management of ITP
A study testing atorvastatin, NAC, and romiplostim in people with Immune Thrombocytopenic Purpura, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- atorvastatin, NAC, and romiplostim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Atorvastatin Combined With N-Acetyl-L-Cysteine Plus Romiplostim for Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia
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.
Read the detailed description
This is a prospective, single-arm trial designed to investigate whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim can induce a sustained response off-treatment (SRoT) in adult patients with immune thrombocytopenia (ITP) who experienced failure of first-line corticosteroid therapy. In this study, SRoT is defined as an off-treatment period during which the platelet count remains above 30×10⁹/L in the absence of bleeding events or rescue therapy. The primary endpoint was the proportion of patients who achieved SRoT by Week 24 after the discontinuation of romiplostim. 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. During the initial 24 weeks, romiplostim was initiated at a starting dose of 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. 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.
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- atorvastatin, NAC, and romiplostim
- Keywords
- immune thrombocytopenia, atorvastatin, N-acetyl-L-cysteine, romiplostim, sustained response off-treatment
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| combined therapy | Experimental | atorvastatin 20mg qd , N-acetyl-L-cysteine (NAC) 400mg tid, and romiplostim Receives: Drug: atorvastatin, NAC, and romiplostim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks post-treatment cessation
Secondary outcomes (7)
24-week SCRoT rate
Sustained complete response off-treatment (SCRoT) rate was defined as the proportion of patients who maintain a platelet count of ≥100×10⁹/L without active bleeding after treatment discontinuation.
Measured: 24 weeks after treatment discontinuation
ORR
Overall response rate (ORR) is defined as the proportion of patients who achieve platelet count ≥30×10^9/L and more than twice the baseline level, with no signs of active bleeding.
Measured: Up to the end of week 24
CR rate
Complete response (CR) rate is defined as the proportion of patients who achieve a platelet count ≥100×10⁹/L with no signs of active bleeding.
Measured: Up to the end of week 24
TTR
Time to response (TTR) is defined as the days from treatment initiation to first platete count reaching ≥30×10^9/L
Measured: Up to the end of week 24
Sustained response
Platelet count ≥30×10⁹/L and at least doubled from baseline on at least three of four scheduled visits during the final 8 weeks of the initial 24-week treatment phase without active bleeding.
Measured: Up to the end of week 24
Bleeding events
Bleeding incidence and severity per WHO bleeding score
Measured: Up to the end of week 24; Week 25 to 24 weeks post-treatment cessation
Adverse Events
The proportion of patients with adverse events
Measured: Up to the end of week 24; Week 25 to 24 weeks post-treatment cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Haixia, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662525
- Sponsor's protocol ID
- 2025PHD049-001
- Status last verified
- Jun 2026
- First submitted
- 16 May 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Combined With N-Acetyl-L-Cysteine Plus Romiplostim for Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia
- ClinicalTrials.gov ID
- NCT07662525
- Acronym / sponsor ID
- 2025PHD049-001
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- immune thrombocytopenia, atorvastatin, N-acetyl-L-cysteine, romiplostim, sustained response off-treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm trial designed to investigate whether atorvastatin combined with N-acetyl-L-cysteine (NAC) plus romiplostim can induce a sustained response off-treatment (SRoT) in adult patients with immune thrombocytopenia (ITP) who experienced failure of first-line corticosteroid therapy. In this study, SRoT is defined as an off-treatment period during which the platelet count remains above 30×10⁹/L in the absence of bleeding events or rescue therapy. The primary endpoint was the proportion of patients who achieved SRoT by Week 24 after the discontinuation of romiplostim. 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. During the initial 24 weeks, romiplostim was initiated at a starting dose of 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. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combined therapy | Experimental | Drug: atorvastatin, NAC, and romiplostimatorvastatin 20mg qd , N-acetyl-L-cysteine (NAC) 400mg tid, and romiplostim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atorvastatin, NAC, and romiplostimFrom 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. | Drug | combined therapy |
Primary outcome
24-week SRoT rate
Time frame: 24 weeks post-treatment cessation
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.
7 secondary outcomes
24-week SCRoT rate
Time frame: 24 weeks after treatment discontinuation
ORR
Time frame: Up to the end of week 24
CR rate
Time frame: Up to the end of week 24
TTR
Time frame: Up to the end of week 24
Sustained response
Time frame: Up to the end of week 24
Bleeding events
Time frame: Up to the end of week 24; Week 25 to 24 weeks post-treatment cessation
Adverse Events
Time frame: Up to the end of week 24; Week 25 to 24 weeks post-treatment cessation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atorvastatin, NAC, and romiplostim in people with Immune Thrombocytopenic Purpura, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fu Haixia, Dr. (+861088326002, fuhaixia_210@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-week SRoT rate (time frame: 24 weeks post-treatment cessation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.