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Study Summary
This trial is testing a new drug for chronic ITP in children to see if it is effective and safe.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have not received IV immunoglobulin or anti-D immunoglobulin in the last 3 weeks.I am willing and able to follow the study rules.I have had my spleen removed in the last 3 months or will have it removed.I am not pregnant or nursing.I have conditions that increase my risk of blood clots, making PANZYGA treatment risky for me.I have been using birth control consistently and will continue to do so during the study.I am currently experiencing a significant bleeding episode.I have low platelet counts not caused by AIDS, lupus, drugs, or a congenital condition.My thrombopoietin receptor agonist dose has changed or will change soon.I am between 1 and 17 years old.Your blood platelet count is less than 30,000 at the start of the study.I have been diagnosed with Chronic ITP according to ASH 2019 guidelines.My dose of oral immunosuppressants has been stable for the last 2 months, and I don't plan to change it soon.I have not had emergency surgery in the last 4 weeks.You have a known deficiency of immunoglobulin A (IgA) and antibodies against IgA.I have or might have HIV, HBV, or HCV.I have Evans syndrome with at least two symptoms: low platelets, anemia, or low neutrophil count.My liver and kidney function tests are within normal limits.You have had problems with alcohol or drug abuse in the past year.My condition did not improve after treatment with IGIV or anti-D.My hormone therapy dose has changed in the last 2 months or will change before Day 32.
- Group 1: Panzyga
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still vacancies for participants in this trial?
"This clinical trial, posted on the 21st of January 2020 and subsequently updated on the 6th of December 2021, is currently seeking participants."
Are there any establishments in North America offering this trial?
"This research is accepting patients at 8 sites, including Philadelphia, Columbus and Providence. To minimize travel requirements for participants of the trial, it is suggested to select a clinic that is geographically proximal."
Could I qualify to take part in this experiment?
"Eligibility criteria dictate that all applicants must suffer from chronic immune thrombocytopenia and be between the ages of 1 Year and 18. The recruitment goal for this trial is 20 participants."
Is the trial seeking participants who are fifty years of age and older?
"To qualify for this medical study, participants must be aged between 1 and 18 years old."
In what treatments is Panzyga regularly employed?
"Panzyga is used to treat a variety of primary immunodeficiencies, such as bruton's agammaglobulinemia and agammaglobulinemia."
How many research participants are engaged in this investigation?
"Affirmative. According to clinicaltrials.gov, this research is actively recruiting volunteers and was initially posted on the 21st of January 2020 before its most recent update occurring on December 6th 2021. The study needs 20 participants from 8 distinct locations."
Has the Panzyga drug been authorized by the Food and Drug Administration?
"There is ample evidence to suggest Panzyga is safe, so it was rated a 3 on our scale. This medication has been given the green light in Phase 4 of clinical trials."
What other experiments have been done to evaluate the efficacy of Panzyga?
"Panzyga was initially studied at Montefiore Medical Center in 2008 and, since then, 166 trials have been concluded. Currently there are 35 ongoing clinical investigations with a significant portion conducted out of Philadelphia, Pennsylvania."
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