Acquired Thrombotic Thrombocytopenic PurpuraPhase 2NCT04021173
A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)
A Phase 2 study testing Anfibatide in people with Acquired Thrombotic Thrombocytopenic Purpura, run by Lee's Pharmaceutical Limited at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Thrombotic Thrombocytopenic Purpura
- What is being tested?
- Anfibatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- Jul 2019to Nov 2021
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male subjects with 18 years of age or older.
- Subjects with diagnosis of TTP.
- Necessitating plasma exchange.
- Obtained, signed and dated informed consent.
Who cannot join
- Platelet count greater or equal to 100*10^9/μL.
- Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate <30ml/min.
- Uncontrolled severe active infection.
- Known congenital TTP.
- Subjects with malignant tumors in the past 5 years.
- Other diseases that cause microangiopathy hemolytic anemia and thrombocytopenia, such as disseminated intravascular coagulation (DIC), antiphospholipid antibody syndrome, hemolytic uremic syndrome, malignant hypertension, and transplant-related microangiopathy.
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- Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.
- Severe active bleeding or progressive aggravation of bleeding symptoms.
- Subjects who have received plasmapheresis during the treatment of the onset of the disease.
- Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.
- Subject who have participated in other clinical trials related to Anfibatide.
- Severe or life threatening clinical condition other than TTP that would impair participation in the trial.
- Life expectation less than 1 week.
- Known to be allergic to the drugs or ingredients in the study.
- Inability to follow programme requirements and procedures.
- Subjects who are not eligible to participate in this clinical study as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ruijing Hospital
Shanghai, Shanghai Municipality
Weili Zhao, MD, 13512112076, zhaoweili-sih@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)
This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.
Read the detailed description
The study will consist of 3 periods: screening(up to 7 days), treatment and follow-up(up to 3 months). Subjects are assigned in a 1:1 ratio to Anfibatide or placebo during plasma exchange with the use of a computerized randomization schedule. The administration is 5 IU/60kg intravenous infusion and 0.002 IU/kg/h continuous intravenous infusion. Plasma exchange as the main treatment method is performed daily on the 5th day of solstice and then adjusted to every other day. Fresh frozen plasma（FFP）and cryoprecipitate-reduced plasma are preferred. Subjects will receive the study drug immediately after daily plasma exchange.
- Being tested
- Anfibatide, Placebos
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnfibatideDrug
Also called Anti-platelet thrombolysin for injection
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
PlacebosDrug
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Anfibatide | Experimental | Not described Receives: Drug: Anfibatide |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to response of treatment
Time to response of treatment ,defined by a recovery of platelets ≥100*10^9/l
Measured: up to 21days
Secondary outcomes (1)
Remission rate
Number of subjects with remission
Measured: up to 21days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study startJul 2019 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Thrombotic Thrombocytopenic PurpuraStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weili Zhao, MD, Study director, Shanghai Ruijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021173
- Sponsor's protocol ID
- APT-ZK-201901
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 17 Jul 2019
- 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 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)
- ClinicalTrials.gov ID
- NCT04021173
- Acronym / sponsor ID
- APT-ZK-201901
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2019 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 16 Jul 2019 (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 multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.
Detailed description
The study will consist of 3 periods: screening(up to 7 days), treatment and follow-up(up to 3 months). Subjects are assigned in a 1:1 ratio to Anfibatide or placebo during plasma exchange with the use of a computerized randomization schedule. The administration is 5 IU/60kg intravenous infusion and 0.002 IU/kg/h continuous intravenous infusion. Plasma exchange as the main treatment method is performed daily on the 5th day of solstice and then adjusted to every other day. Fresh frozen plasma（FFP）and cryoprecipitate-reduced plasma are preferred. Subjects will receive the study drug immediately after daily plasma exchange.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anfibatide | Experimental | Drug: Anfibatide |
| Placebo | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female and male subjects with 18 years of age or older.
- Subjects with diagnosis of TTP.
- Necessitating plasma exchange.
- Obtained, signed and dated informed consent.
Key exclusion criteria (16 listed)
- Platelet count greater or equal to 100*10^9/μL.
- Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate <30ml/min.
- Uncontrolled severe active infection.
- Known congenital TTP.
- Subjects with malignant tumors in the past 5 years.
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 |
|---|---|---|
| AnfibatideAlso: Anti-platelet thrombolysin for injection5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion | Drug | Anfibatide |
| Placebos5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion | Drug | Placebo |
Primary outcome
Time to response of treatment
Time frame: up to 21days
Time to response of treatment ,defined by a recovery of platelets ≥100*10^9/l
1 secondary outcome
Remission rate
Time frame: up to 21days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- 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. This study is not recruiting at the moment.
Weili Zhao, MD study director
Shanghai Ruijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anfibatide in people with Acquired Thrombotic Thrombocytopenic Purpura, run by Lee's Pharmaceutical Limited 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 16 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: status not confirmed, as of the sponsor's last update on 17 Jul 2019. 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. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, MD (13512112076, zhaoweili-sih@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to response of treatment (time frame: up to 21days). 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 17 Jul 2019.