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NCT ID: NCT03460782 No longer available - Glioblastoma Clinical Trials

An Expanded Access Program of Ipilimumab for Patients With Glioblastomas and Gliomas

Start date: n/a
Phase:
Study type: Expanded Access

IPILIMUMAB Extended Access Program for patients who received chemotherapy and / or radiation therapy before the protocol, before or after the operation.

NCT ID: NCT02783001 No longer available - HIV Infections Clinical Trials

Expanded Access Program for Maraviroc At Multiple Centers

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

To provide access to maraviroc to patients who have limited or no therapeutic treatment options and to collect more safety data in a broader patient population.

NCT ID: NCT02389933 No longer available - Clinical trials for Heart Failure With Reduced Ejection Fraction (HF-rEF)

Multiple Patient Program to Ensure Access to LCZ696 Treatment to Patients Diagnosed With Heart Failure With Reduced Ejection Fraction (HF-rEF)

Start date: n/a
Phase:
Study type: Expanded Access

Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to life-saving treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.

NCT ID: NCT02297529 No longer available - Clinical trials for Unresected Stage IIIB to IVM1c Melanoma

Expanded Access Study of Talimogene Laherparepvec for Treatment of Subjects With Unresected Stage IIIB-IVM1c Melanoma

Start date: n/a
Phase:
Study type: Expanded Access

The study is a phase 3b, multicenter, open-label, single-arm study designed to provide expanded access of Talimogene Laherparepvec for the treatment of subjects with unresected stage IIIB to IVM1c melanoma. The study will also evaluate the safety and tolerability of Talimogene Laherparepvec.

NCT ID: NCT02187354 No longer available - Clinical trials for Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia

Expanded Access Protocol - Blinatumomab in Pediatric & Adolescent Subjects With Relapsed/Refractory B-precursor ALL

RIALTO
Start date: n/a
Phase:
Study type: Expanded Access

Primary Objective: To estimate the incidence of treatment-emergent and treatment-related adverse events during treatment with blinatumomab in pediatric and adolescent subjects with B-precursor ALL in second or later bone marrow relapse, in any marrow relapse after alloHSCT, or refractory to other treatments Secondary Objective(s): To describe key efficacy outcomes, including incidence of complete response (CR) within 2 cycles of blinatumomab, minimal residual disease (MRD) remission within 2 cycles of blinatumomab, relapse free survival (RFS), overall survival (OS), incidence of alloHSCT, and 100-day mortality after alloHSCT. Hypotheses: A formal statistical hypothesis will not be tested. The incidence of treatment-emergent and treatment-related adverse events will be estimated. Study Endpoints: - Incidence of treatment-emergent and treatment-related adverse events - Incidence of CR within 2 cycles of blinatumomab - MRD remission within 2 cycles of blinatumomab - RFS - OS - Incidence of alloHSCT - 100-day mortality after alloHSCT Study Design: Multi-center, open-label, single-arm expanded access protocol

NCT ID: NCT01784562 No longer available - Clinical trials for Hypertension, Pulmonary

Riociguat in Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

EAS
Start date: n/a
Phase: N/A
Study type: Expanded Access

The aim of the study is to assess safety, tolerability and clinical effects of different doses of riociguat in patients with inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and who are not satisfactorily treated and cannot participate in any other CTEPH trial. In the US the study runs as an Expanded Access program under 21 CFR 312.320.

NCT ID: NCT01776996 No longer available - Clinical trials for Infection, Human Immunodeficiency Virus

An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Start date: n/a
Phase: N/A
Study type: Expanded Access

This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.

NCT ID: NCT01538680 No longer available - Clinical trials for Colorectal Neoplasms

Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

CONSIGN
Start date: n/a
Phase:
Study type: Expanded Access

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access. Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint of this study will be safety.

NCT ID: NCT01508286 No longer available - Hepatitis C Clinical Trials

Early Access Program of Telaprevir With Peginterferon and Ribavirin in Chronic Hepatitis C Subjects

Start date: n/a
Phase: Phase 3
Study type: Expanded Access

The purpose of this early access program is to provide telaprevir to patients with a specific type of hepatitis C viral infection (termed 'genotype 1') who are expected to benefit from telaprevir-based therapy but who reside in countries in which telaprevir is not yet commercially available and who are not eligible for enrollment into a clinical study of telaprevir. The study also aims to collect information on the safety and adverse events with telaprevir treatment in combination with peginterferon alfa and ribavirin, which is typically used to treat patients with hepatitis C. In addition to hepatitis C viral infection, patients in this study will also have a diagnosis of liver fibrosis and compensated liver disease.

NCT ID: NCT01196208 No longer available - Clinical trials for Lymphoma, Non-Hodgkin

A Treatment-Option Protocol to Provide Brentuximab Vedotin to Eligible Patients Completing Studies SGN35-005 or C25001

Start date: n/a
Phase:
Study type: Expanded Access

The purpose of this study is to provide the option of brentuximab vedotin treatment to eligible patients in studies SGN35-005 and C25001