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NCT ID: NCT04558918 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Study of Efficacy and Safety of Twice Daily Oral LNP023 in Adult PNH Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

APPLY-PNH
Start date: January 25, 2021
Phase: Phase 3
Study type: Interventional

This study was a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this Phase 3 study in PNH patients presenting with residual anemia despite treatment with anti-C5 antibody, was to determine whether iptacopan is efficacious and safe for the treatment of PNH through demonstration of superiority of iptacopan compared to anti-C5 antibody treatment.

NCT ID: NCT04557735 Recruiting - Clinical trials for Thrombotic Microangiopathy

Study of Ravulizumab in Pediatric Participants With HSCT-TMA

Start date: December 7, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to < 18 years of age, with HSCT-TMA. The treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.

NCT ID: NCT04557462 Recruiting - Clinical trials for Primary IgA Nephropathy

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

NCT ID: NCT04557449 Recruiting - Prostate Cancer Clinical Trials

Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors

CDK4i
Start date: September 23, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy.

NCT ID: NCT04557384 Terminated - Clinical trials for Advanced Solid Tumor

A Study of Ramucirumab (LY3009806) Given by Injection Under the Skin in Participants With Advanced Cancer

Start date: February 23, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study in participants with advanced cancer is to learn more about the safety of ramucirumab when given by injection under the skin (subcutaneous injection). The study will also measure how much ramucirumab gets into the bloodstream and how long it takes the body to get rid of it.

NCT ID: NCT04557163 Completed - Healthy Subjects Clinical Trials

Drug-drug Interaction Study With TS-142 in Healthy Adult Subjects (Concomitant Administration of Itraconazole)

Start date: October 13, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, single-center, single-sequence study to evaluate the concomitant effects of the potent CYP3A inhibitor itraconazole on the single-dose pharmakokinetics, safety and tolerability of oral TS-142 in healthy subjects.

NCT ID: NCT04557085 Active, not recruiting - Partial Seizure Clinical Trials

Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS

Start date: March 8, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, adjunctive therapy study in subjects with POS, with optional OLE. The study consists of 4 periods as follows: An 8-week of Screening/Baseline Period, 24-week of Double-blind Treatment Period (including a 18-week Titration Phase and 6-week Maintenance Phase), 52-week of Open-label Extension (OLE) Period (applicable for subjects who participate in the OLE) and up to 5-week of End of Study (EOS) Follow-up Period. The purpose of this study is to evaluate the efficacy and safety of 100, 200 and 400 mg/day of cenobamate as adjunctive therapy compared with placebo in subjects with partial onset seizures (POS). The study will also evaluate the long-term safety and tolerability of cenobamate adjunctive therapy in subjects with POS who have completed the double-blind treatment period.

NCT ID: NCT04553133 Active, not recruiting - Breast Cancer Clinical Trials

PF-07104091 as a Single Agent and in Combination Therapy

Start date: September 16, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.

NCT ID: NCT04552899 Terminated - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis

STARSCAPE
Start date: March 19, 2021
Phase: Phase 3
Study type: Interventional

This phase III study will evaluate the efficacy, safety and pharmacokinetics (PK) of recombinant human pentraxin-2 (rhPTX-2; PRM-151) zinpentraxin alfa, compared with placebo in participants with idiopathic pulmonary fibrosis (IPF).

NCT ID: NCT04552470 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06882961 in Japanese Adults With Type 2 Diabetes Mellitus

Start date: October 26, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double blind (sponsor open), parallel, placebo controlled, twice daily oral dosing study of PF 06882961 in adult Japanese participants with T2DM inadequately controlled on diet and exercise alone.