CompletedPhase 2

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

Taiwan14 participantsStarted 2008-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

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.

What they're measuring

Platelet Response

Timeframe: 17 weeks

Trial details

NCT IDNCT00860600

SponsorPhytoHealth Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-08

View on ClinicalTrials.gov More Idiopathic Thrombocytopenic Purpura (ITP) trials