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Closed (no longer recruiting)Last updated: 15 August 2023

This phase I/II trial is trying to understand the safety and effectiveness of a targeted therapy (PRN1008) in people with relapsed Immune ThrombocytopeniaAn Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia

Clinical summary Eligibilty Participating hospitals Support

Clinical summary

Summary

This is a 2 part, adaptive, open-label dose-finding study of PRN1008 in people with Immune Thrombocytopenic Purpura (ITP). Part A enrols people with ITP who are refractory or relapsed with no available and approved therapeutic options. Eligible patients have a platelet count <30,000 ¼l="" on="" two="" counts="" no="" sooner="" than="" 7="" days="" apart="" in="" the="" 15="" days="" before="" treatment="" begins.="" the="" active="" treatment="" period="" is="" 24="" weeks="" and="" the="" post-treatment="" follow-up="" period="" is="" 4="" weeks.="" in="" the="" dose-finding="" part="" of="" the="" study,="" each="" patient="" enrolled="" in="" the="" study="" is="" allowed="" to="" up-titrate="" their="" dose="" after="" 28="" days="" of="" prn1008="" therapy,="" if="" they="" do="" not="" experience="" a="" platelet="" response="" or="" a="" dose-limiting="" toxicity="" (dlt)="" at="" the="" last="" dose="" level.="" patients="" who="" respond="" to="" prn1008="" per="" protocol="" may="" enter="" a="" long="" term-extension.="" part="" b="" of="" the="" study="" will="" include="" people="" with="" itp="" who="" have="" relapsed="" or="" have="" insufficient="" response="" to="" prior="" therapies.="" eligible="" patients="" will="" have="" a="" platelet="" count=""><30,000 µl="" on="" two="" occasions="" no="" less="" than="" 7="" days="" apart,="" within="" 15="" days="" before="" treatment="" begins="" and="" a="" platelet="" count="" of="" â‰¤35,000/âµl="" on="" study="" day="" 1="" (sd1).="" the="" study="" consists="" of="" a="" 28-day="" screening="" period,="" 24-week="" active="" treatment="" period,="" and="" a="" long-term="" extension.="" after="" the="" last="" dose="" of="" prn1008="" there="" will="" be="" a="" 4-week="" safety="" follow-up="">

Conditions

This trial is treating patients with Immune Thrombocytopenia.

Cancer

Blood Cancers Blood

Age

People 18 - 80

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

NCT03395210
2019.282 PRINCIPIA BIOPHARMA - PRN1008-010 - CT1191

Commercial Sponsor

Principia Biopharma, a Sanofi Company

Scientific Title

An Adaptive, Open-Label, Dose-Finding, Phase 1/2 Study Investigating the Safety, Pharmacokinetics, and Clinical Activity of PRN1008, an Oral BTK Inhibitor, in Patients With Relapsed Immune Thrombocytopenia

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Eligibility

Inclusion

You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
You have had treatment, but your cancer has come back.

Exclusion

You have certain types of non-cancer medical conditions.
You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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