Idiopathic Thrombocytopenic Purpura (ITP)Phase 2NCT00860600
Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients
A Phase 2 study testing PG2 in people with Idiopathic Thrombocytopenic Purpura (ITP), run by PhytoHealth Corporation at 4 sites in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura (ITP)
- What is being tested?
- PG2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 4 sitesTaiwan
- Study dates
- Sep 2008to Aug 2011
- 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
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
Changhua Christian Hospital
Changhua, 500
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, 807
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
About this study
Official title: 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.
Read the 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.
- Being tested
- PG2
- Keywords
- Idiopathic Thrombocytopenic Purpura (ITP), Platelet Response, PG2 Treatment, Quality of Life, Fatigue, WHO Bleeding score
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG2Drug
Also called PG2 Injection 500 mg
500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time
| Study group | Role | What they receive |
|---|---|---|
| 1. PG2 Treatment: 5 days/week | Experimental | Powder for Injection, 500 mg PG2/500 ml normal saline, 5 days/week, 2 to 4 weeks Receives: Drug: PG2 |
| 2. PG2 Treatment: 3 days/week | Experimental | Powder for Injection, 500 mg PG2/500 ml normal saline, 3 days/week, 2 to 4 weeks Receives: Drug: PG2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Response
Measured: 17 weeks
Secondary outcomes (5)
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
Measured: 17 weeks
The subject incidence of requiring rescue therapy during the treatment period
Measured: 17 weeks
The endogenous TPO and anti-platelet antibody levels
Measured: 17 weeks
Patient's fatigue status (measured by the Brief Fatigue Inventory)
Measured: 17 weeks
Patient's Bleeding Score (measured by the WHO Bleeding Scale)
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic Purpura (ITP)Studies 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
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheng-Fung Lin, M.D., Ph.D., Study chair, E-Da Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860600
- Sponsor's protocol ID
- PH-CP014
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2009
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial of PG2 in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT00860600
- Acronym / sponsor ID
- PH-CP014
- Keywords
- Idiopathic Thrombocytopenic Purpura (ITP), Platelet Response, PG2 Treatment, Quality of Life, Fatigue, WHO Bleeding score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2008 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 12 Mar 2009 (estimated)
- 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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. PG2 Treatment: 5 days/week | Experimental | Drug: PG2Powder for Injection, 500 mg PG2/500 ml normal saline, 5 days/week, 2 to 4 weeks |
| 2. PG2 Treatment: 3 days/week | Experimental | Drug: PG2Powder for Injection, 500 mg PG2/500 ml normal saline, 3 days/week, 2 to 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| PG2Also: PG2 Injection 500 mg500mg/vial, iv infusion, 3 ~ 5 times/week, 2.5 ~ 3.5 hr/time | Drug | 1. PG2 Treatment: 5 days/week, 2. PG2 Treatment: 3 days/week |
Primary outcome
Platelet Response
Time frame: 17 weeks
5 secondary outcomes
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
The subject incidence of requiring rescue therapy during the treatment period
Time frame: 17 weeks
The endogenous TPO and anti-platelet antibody levels
Time frame: 17 weeks
Patient's fatigue status (measured by the Brief Fatigue Inventory)
Time frame: 17 weeks
Patient's Bleeding Score (measured by the WHO Bleeding Scale)
Time frame: 17 weeks
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 4 Jun 2025.
Related trials for Idiopathic Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)
RecruitingPhase 3
A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
RecruitingPhase 2
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
Immune Thrombocytopenia
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
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.
Sheng-Fung Lin, M.D., Ph.D. study chair
E-Da Cancer Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PG2 in people with Idiopathic Thrombocytopenic Purpura (ITP), run by PhytoHealth Corporation at 4 sites in Taiwan.
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 9 inclusion and 17 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 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Taiwan. 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?
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?
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?
Platelet Response (time frame: 17 weeks). 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 4 Jun 2025.