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| Sponsor: | PhytoHealth Corporation |
|---|---|
| Information provided by (Responsible Party): | PhytoHealth Corporation |
| ClinicalTrials.gov Identifier: | NCT00860600 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Thrombocytopenic Purpura (ITP) |
Drug: PG2 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Clinical Trial of PG2 in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) |
| Enrollment: | 14 |
| Study Start Date: | September 2008 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1. PG2 Treatment: 5 days/week |
Drug: PG2
500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
|
| Experimental: 2. PG2 Treatment: 3 days/week |
Drug: PG2
500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Taiwan | |
| Changhua Christian Hospital | |
| Changhua, Taiwan, 500 | |
| Chung-Ho Memorial Hospital, Kaohsiung Medical University | |
| Kaohsiung, Taiwan, 807 | |
| National Cheng Kung University Hospital | |
| Tainan, Taiwan, 704 | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
| Study Chair: | Sheng-Fung Lin, M.D., Ph.D. | Chung-Ho Memorial Hospital, Kaohsiung Medical University |
| Principal Investigator: | Tsai-Yun Chen, M.D. | National Cheng-Kung University Hospital |
| Principal Investigator: | Cheng-Shyong Chang | Changhua Christian Hospital |
| Principal Investigator: | Sheng-Yi Huang | National Taiwan University Hospital |
More Information
| Responsible Party: | PhytoHealth Corporation |
| ClinicalTrials.gov Identifier: | NCT00860600 History of Changes |
| Other Study ID Numbers: | PH-CP014 |
| Study First Received: | March 10, 2009 |
| Last Updated: | May 10, 2012 |
| Health Authority: | Taiwan: Department of Health Taiwan: Institutional Review Board United States: Food and Drug Administration |
|
Idiopathic Thrombocytopenic Purpura (ITP) Platelet Response PG2 Treatment |
Quality of Life Fatigue WHO Bleeding score |
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Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations |
Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases |