Primary Immune ThrombocytopeniaEarly Phase 1NCT05551624
Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine
A Early Phase 1 study testing Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet in people with Primary Immune Thrombocytopenia, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial summary
The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Primary Immune Thrombocytopenia
- What is being tested?
- Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteMexico
- Study dates
- 4 Jul 2018to 23 Jan 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients that give their informed consent before the procedures of study
- Thrombocytopenia before intervention (<100 x10^9 /L)
- Patients of either biological sex older than 15 years old
- Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse
- If the patient is taking steroid based treatment, the dose need to be stable before intervention.
Who cannot join
- Patients with secondary immune thrombocytopenia
- Pregnant patients
- Patients with hypersensitivity to study treatments
- Patients that are taking anticoagulant medication or any drug that have an effect on platelet count
- Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit.
- Elevation of serum levels of Creatinine or bilirubins above 1.5 mg/dl
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- Any cancer diagnosis
- Coronary heart disease, congestive heart failure, uncontrolled hypertension or arrhythmias.
- Previous autoimmune disease diagnosis including: systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280
About this study
Official title: Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine in Patients With Primary Immune Thrombocytopenia Resistant to Steroid Treatment or in Relapse: An Exploratory Clinical Trial
The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment.
Read the detailed description
Evaluate the efficacy in the elevation of platelet count of the combination of atorvastatin and N-acetyl cysteine in patients with immune thrombocytopenia resistant to steroid therapy or with relapse after treatment, a prospective, proof of concept clinical trial.
- Conditions
- Primary Immune Thrombocytopenia
- Being tested
- Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet
- Keywords
- Immune thrombocytopenia, Atorvastatin, N-acetylcysteine, Steroids
- 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 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tabletDrug
Oral tablets administered daily, atorvastatin once a day and N-acetylcysteine every 8 hours
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin + N-acetylcysteine | Experimental | Patients included in the study received an oral treatment of Atorvastatin 40 mg daily and N-acetylcysteine 400 mg every 8 hours, for at least 1 month (up to 12 months) Receives: Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
Blood samples of all participants will be taken previous to the intervention of study and in the 1, 3, 6, adn 12 month, this with the objective of evaluate changes in platelet count after intervention expecting to elevate the platelet count.
Measured: Baseline and 1, 3, 6, and 12 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start4 Jul 2018
- Primary completion11 Dec 2019
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune ThrombocytopeniaStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single group, exploratory (proof of concept) clinical trial to evaluate the effect in serum platelet count of Atorvastatin plus N-acetylcysteine in patients with primary immune thrombocytopenia resistent to steroid therapy or in relapse
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrique Cervantes-Perez, Hospital Civil de Guadalajara
- Investigators
- Enrique Cervantes-Perez, MD, MSc, Principal investigator, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551624
- Sponsor's protocol ID
- 178/19
- Status last verified
- Sep 2022
- First submitted
- 20 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine in Patients With Primary Immune Thrombocytopenia Resistant to Steroid Treatment or in Relapse: An Exploratory Clinical Trial
- ClinicalTrials.gov ID
- NCT05551624
- Acronym / sponsor ID
- 178/19
- Conditions
- Primary Immune Thrombocytopenia
- Keywords
- Immune thrombocytopenia, Atorvastatin, N-acetylcysteine, Steroids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 4 Jul 2018 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 22 Sep 2022 (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.
The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment.
Detailed description
Evaluate the efficacy in the elevation of platelet count of the combination of atorvastatin and N-acetyl cysteine in patients with immune thrombocytopenia resistant to steroid therapy or with relapse after treatment, a prospective, proof of concept clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single group, exploratory (proof of concept) clinical trial to evaluate the effect in serum platelet count of Atorvastatin plus N-acetylcysteine in patients with primary immune thrombocytopenia resistent to steroid therapy or in relapse
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin + N-acetylcysteine | Experimental | Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tabletPatients included in the study received an oral treatment of Atorvastatin 40 mg daily and N-acetylcysteine 400 mg every 8 hours, for at least 1 month (up to 12 months) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients that give their informed consent before the procedures of study
- Thrombocytopenia before intervention (<100 x10^9 /L)
- Patients of either biological sex older than 15 years old
- Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse
- If the patient is taking steroid based treatment, the dose need to be stable before intervention.
Key exclusion criteria (9 listed)
- Patients with secondary immune thrombocytopenia
- Pregnant patients
- Patients with hypersensitivity to study treatments
- Patients that are taking anticoagulant medication or any drug that have an effect on platelet count
- Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit.
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 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tabletOral tablets administered daily, atorvastatin once a day and N-acetylcysteine every 8 hours | Drug | Atorvastatin + N-acetylcysteine |
Primary outcome
Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
Time frame: Baseline and 1, 3, 6, and 12 months after intervention
Blood samples of all participants will be taken previous to the intervention of study and in the 1, 3, 6, adn 12 month, this with the objective of evaluate changes in platelet count after intervention expecting to elevate the platelet count.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
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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. This study is not recruiting at the moment.
Enrique Cervantes-Perez, MD, MSc principal investigator
Hospital Civil de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet in people with Primary Immune Thrombocytopenia, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 5 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: finished, as of the sponsor's last update on 22 Sep 2022. 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 Mexico. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months (time frame: Baseline and 1, 3, 6, and 12 months after intervention). 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 22 Sep 2022.