Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT00860600
First received: March 10, 2009
Last updated: December 3, 2012
Last verified: December 2012
  Purpose

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.


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)

Resource links provided by NLM:


Further study details as provided by PhytoHealth Corporation:

Primary Outcome Measures:
  • Platelet Response [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The subject incidence of requiring rescue therapy during the treatment period [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]
  • The endogenous TPO and anti-platelet antibody levels [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  • Patient's fatigue status (measured by the Brief Fatigue Inventory) [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
  • Patient's Bleeding Score (measured by the WHO Bleeding Scale) [ Time Frame: 17 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: September 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. PG2 Treatment: 5 days/week
Powder for Injection, 500 mg PG2/500 ml normal saline, 5 days/week, 2 to 4 weeks
Drug: PG2
500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
Other Name: PG2 Injection 500 mg
Experimental: 2. PG2 Treatment: 3 days/week
Powder for Injection, 500 mg PG2/500 ml normal saline, 3 days/week, 2 to 4 weeks
Drug: PG2
500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
Other Name: PG2 Injection 500 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older.
  2. 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.
  3. 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.
  4. The subject or his/her legal delegate has signed an informed consent form.
  5. Absence of other conditions that, in the opinion of the investigator, could cause thrombocytopenia.
  6. 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.
  7. 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.
  8. If a subject is a female of child-bearing potential, she must have a negative result on a urine-based HCG pregnancy test.
  9. 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:

  1. 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.
  2. The subject is known to be intolerant to any component of the investigational product.
  3. The subject has received any live virus vaccine within the last 3 months.
  4. The subject has received an IVIG preparation within 1 month prior to screening.
  5. The subject is currently receiving, or has received, any investigational agent within one month prior to screening.
  6. The subject has received Rituximab within 3 months before screening.
  7. The subject is pregnant or is nursing.
  8. The subject is diagnosed of having HIV.
  9. The subject, at screening, has levels greater than 2.5 times the upper limit of normal liver function of alanine aminotransferase or aspartate aminotransferase.
  10. 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.
  11. The subject has a history of deep vein thrombosis (DVT) or thrombotic complications.
  12. The subject has any history of hyperviscosity, transient ischemic attack (TIA), stroke, other thromboembolic event, or unstable angina.
  13. 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.
  14. 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.
  15. The subject is unlikely to adhere to the protocol requirements of the study or is likely to be uncooperative.
  16. The subject is unwilling or unable to answer the quality of life questionnaires i.e. the BFI.
  17. The subject has undergone splenectomy within 4 weeks prior to screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860600

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
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
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

Additional Information:
No publications provided

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: December 3, 2012
Health Authority: Taiwan: Department of Health
Taiwan: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by PhytoHealth Corporation:
Idiopathic Thrombocytopenic Purpura (ITP)
Platelet Response
PG2 Treatment
Quality of Life
Fatigue
WHO Bleeding score

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 18, 2014