- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00860600
Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients
November 23, 2023 updated by: PhytoHealth Corporation
The Clinical Trial of PG2 in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
This was a phase II multi-center, randomized, open-label study with two parallel study groups to evaluate the efficacy and safety of PG2 in ITP patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of this exploratory study is to evaluate the efficacy of PG2 in raising the platelet counts in ITP patients using two dosing schedules.
The secondary objective is to determine the safety of PG2 treatment among these patients.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Changhua, Taiwan, 500
- Changhua Christian Hospital
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Kaohsiung, Taiwan, 807
- Chung-Ho Memorial Hospital, Kaohsiung Medical University
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 100
- National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or older.
- Confirmed diagnosis of chronic ITP, according to The American Society of Hematology (ASH) Guidelines, for at least 6 months and have received one or more prior conventional treatments for ITP.
- Patient's platelet count of less than 50,000 per cubic millimeter at enrollment, platelet count is calculated from the mean of 2 platelet counts taken during the screening period and that on day1.
- The subject or his/her legal delegate has signed an informed consent form.
- Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
- If subjects are currently being treated with corticosteroids, the treatment regimen/dose must have been stable (±25% total dose/day) for a minimum of 4 weeks before screening. However, subjects must remain on a stable treatment regimen. If there is any intent to alter the corticosteroid treatment regimen (e.g., tapering of corticosteroids) before Day 10, subjects may not be included in the study.
- If subjects are currently being treated with cyclophosphamide, azathioprine or attenuated androgens, the treatment regimen and dose must have been stable (±25% total dose/day) for a minimum of 3 months before screening. However, if there is any intent to alter the treatment regimen before Day 10, subjects may not be included in the study.
- If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.
- If a subject is of child-bearing potential, he/she must practice contraception by using a method of proven reliability for the duration of the study.
Exclusion Criteria:
- The subject has a history of any severe or anaphylactic reaction to blood or any blood-derived product, or any severe reaction to IVIG or any other IgG preparation.
- The subject is known to be intolerant to any component of the investigational product.
- The subject has received any live virus vaccine within the last 3 months.
- The subject has received an IVIG preparation within 1 month prior to screening.
- The subject is currently receiving, or has received, any investigational agent within one month prior to screening.
- The subject has received Rituximab within 3 months before screening.
- The subject is pregnant or is nursing.
- The subject is diagnosed of having HIV.
- The subject, at screening, has levels greater than 2.5 times the upper limit of normal liver function of alanine aminotransferase or aspartate aminotransferase.
- The subject has a severe renal impairment (defined as serum creatinine greater than 2 times the upper limit of normal or BUN greater than 2.5 times the upper limit of normal for range); or the subject is on dialysis.
- The subject has a history of deep vein thrombosis (DVT) or thrombotic complications.
- The subject has any history of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
- The subject suffers from any acute or chronic medical conditions (e.g., renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing enteropathy) that, in the opinion of the investigator, may interfere with the conduct of the study.
- The subject has an acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (defined as an absolute neutrophil count (ANC) < 1 x 109/L) or has been diagnosed as non-ITP patients.
- The subject is unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.
- The subject is unwilling or unable to answer the quality of life questionnaires i.e. the BFI.
- The subject has undergone splenectomy within 4 weeks prior to screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1. PG2 Treatment: 5 days/week
Powder for Injection, 500 mg PG2/500 ml normal saline, 5 days/week, 2 to 4 weeks
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500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
Other Names:
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Experimental: 2. PG2 Treatment: 3 days/week
Powder for Injection, 500 mg PG2/500 ml normal saline, 3 days/week, 2 to 4 weeks
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500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Platelet Response
Time Frame: 17 weeks
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17 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The total number of bleeding events Grade 2 or higher for each subject during the treatment period, or till the time of end-of-study visit for early withdrawal patients
Time Frame: 17 weeks
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17 weeks
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The subject incidence of requiring rescue therapy during the treatment period
Time Frame: 17 weeks
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17 weeks
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The endogenous TPO and anti-platelet antibody levels
Time Frame: 17 weeks
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17 weeks
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Patient's fatigue status (measured by the Brief Fatigue Inventory)
Time Frame: 17 weeks
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17 weeks
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Patient's Bleeding Score (measured by the WHO Bleeding Scale)
Time Frame: 17 weeks
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17 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Sheng-Fung Lin, M.D., Ph.D., E-Da Cancer Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
March 10, 2009
First Submitted That Met QC Criteria
March 11, 2009
First Posted (Estimated)
March 12, 2009
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Thrombocytopenia
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura
- Purpura, Thrombocytopenic
- Purpura, Thrombocytopenic, Idiopathic
Other Study ID Numbers
- PH-CP014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Thrombocytopenic Purpura (ITP)
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Neufeld, Ellis J, MD, PhDGenentech, Inc.; Biogen; Glaser Pediatric Research Network; Terrana ITP Research...CompletedImmune Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura (ITP)United States
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AmgenCompletedThrombocytopenia | Immune Thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic PurpuraUnited States, Canada, Australia
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AmgenCompletedIdiopathic Thrombocytopenic Purpura | Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
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CSL LimitedCompletedIdiopathic Thrombocytopenic Purpura (ITP)Australia
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Weill Medical College of Cornell UniversityGenentech, Inc.WithdrawnIdiopathic Thrombocytopenic Purpura (ITP)United States
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AmgenCompletedThrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic Purpura
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AmgenCompletedThrombocytopenia | Idiopathic Thrombocytopenic Purpura | Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenic Purpura
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AmgenCompletedThrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITPUnited States, Canada, Australia, Spain
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