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NCT ID: NCT00741910 Completed - Crohn's Disease Clinical Trials

Extension Study of Semapimod 60 mg IV x 3 Days

CD06
Start date: July 2003
Phase: Phase 2
Study type: Interventional

Study CNI-1493-CD06 is an open, single-arm extension studies to CD03 and CD05. CDAI is the only efficacy measure assessed in this study. The safety of multiple courses of semapimod is to be determined by the incidence of clinical and laboratory adverse events.

NCT ID: NCT00741572 Completed - Clinical trials for Interstitial Lung Diseases

Individual Sensitivity for Interstitial Lung Diseases

Start date: August 2008
Phase: N/A
Study type: Observational

Interstitial lung diseases (ILD) is a collective noun for various chronic lung diseases, including sarcoidosis and idiopathic lung fibrosis (IPF). Sarcoidosis is a multi-systemic disease that includes damage to the lungs in 90% of the patients. Generally, the disease can be described as a systemic, granulomatous and antigen-driven disorder. IPF is a disease of only the lungs, in which an unknown cause induces a strong inflammation reaction leading to acute lung damage that ultimately results in the formation of scar tissue and stiffness of the lungs. Unfortunately, the exact cause of ILD is still unknown. It is suggested that environmental and work-related exposure to various triggers can exert an effect on the course of the diseases. Examples of such triggers include bacteria, organic agents such as pollen and cotton dust and inorganic agents like metals and talc. Due to this unknown cause, it is difficult to treat ILD. Consequently, the current guideline is no medication or anti-inflammatory agents in severe cases. Unfortunately, this therapy is not completely effective. Triggers that are suggested to cause ILD can exert their effects via various mechanisms. On the one hand, they can induce an inflammatory reaction as we recently demonstrated for various triggers including instillation material and sicila. During such an inflammatory reaction, cytokines are released that can induce oxidative stress, i.e. an imbalance between the formation of and the protection against reactive oxygen species (ROS). On the other hand, ILD-inducing triggers may directly cause an increased ROS production that subsequently can evoke an inflammatory reaction. The objective of the current study is to investigate the individual sensitivity for the development of ILD after exposure to various triggers. Main focus will be the differences in the formation of and the protection against ROS as well as the occurring inflammatory reaction after exposure to such triggers. Furthermore, a simple blood test will be developed to study and eventually even predict the individual reaction of subjects to various triggers. Finally, to fully characterize the development of ILD after exposure to various triggers, the exhaled air of patients will be studied in order to identify specific markers of oxidative stress and damage.

NCT ID: NCT00740831 Completed - Uterine Myomas Clinical Trials

PGL4001 Versus GnRH-agonist in Uterine Myomas

PEARLII
Start date: August 2008
Phase: Phase 3
Study type: Interventional

This trial will assess the efficacy and safety of PGL4001 versus GnRH agonist, over a 3-month period for the pre-operative treatment of pre-menopausal women suffering from excessive uterine bleeding due to uterine myoma.

NCT ID: NCT00740103 Completed - Crohn's Disease Clinical Trials

Long-term Study of Semapimod (CNI-1493) for Treatment of Crohn's Disease

CD05
Start date: December 2002
Phase: Phase 2
Study type: Interventional

CNI-1493-CD05 is an open-label extension study of CNI-1493-CD04. In the CD05 study, patients are eligible for up to 5 courses of semapimod 60 mg IV x 3 days every 6 - 8 weeks. Primary objective is assessment of the efficacy of cumulative doses of semapimod measured by decrease in Crohn's Disease Activity Index (CDAI).

NCT ID: NCT00739986 Completed - Crohn's Disease Clinical Trials

Semapimod for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment Versus Placebo

CD04
Start date: October 2002
Phase: Phase 2
Study type: Interventional

Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).

NCT ID: NCT00738582 Completed - Clinical trials for Malignant Pleural Mesothelioma

An Efficacy Study of MORAb-009 (Amatuximab) in Subjects With Pleural Mesothelioma

Amatuximab
Start date: December 31, 2008
Phase: Phase 2
Study type: Interventional

This research is being done to find out if pemetrexed and cisplatin work better when given together with an experimental drug called MORAb-009 in patients with malignant pleural mesothelioma.

NCT ID: NCT00738530 Completed - Renal Cell Cancer Clinical Trials

A Study of Avastin (Bevacizumab) Added to Interferon Alfa-2a (Roferon) Therapy in Patients With Metastatic Renal Cell Cancer With Nephrectomy

Start date: June 2004
Phase: Phase 3
Study type: Interventional

This 2-arm study will evaluate the efficacy and safety of Avastin versus placebo in combination with Roferon as first-line treatment in patients with metastatic renal cell cancer (clear cell type) who have had nephrectomy. The anticipated time of study treatment is 1-2 years, and the target sample size is 500+ individuals.

NCT ID: NCT00737932 Completed - Crohn's Disease Clinical Trials

Laquinimod Phase IIa Study in Active Crohn's Disease

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

NCT ID: NCT00737789 Completed - Ulcerative Colitis Clinical Trials

Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.

Start date: November 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study was to demonstrate that mesalazine 4g orally per day once daily (QD) is non-inferior to the reference regimen, mesalazine 4g per day in two divided doses (BID) (2g x 2 per day), in patients with active ulcerative colitis (UC) treated for 8 weeks, in terms of remission evaluated with the Ulcerative Colitis Disease Activity Index (UC-DAI) score and defined as less than or equal to 1. Both groups (4g QD and 2gx2) received an enema containing 1g of mesalazine at bedtime during the initial 4 weeks. Participants in remission at week 8 received an additional 4 weeks of maintenance therapy with 2g oral mesalazine once a day. Participants who did not achieve remission at Week 8 completed the study at week 8.

NCT ID: NCT00737555 Completed - Solid Tumor Clinical Trials

A Study of the Safety and Tolerability of the Addition of CHR-2797 to Paclitaxel in Patients With Advanced or Refractory Tumours

Start date: August 2006
Phase: Phase 1
Study type: Interventional

The treatment of cancer often involves the use of more than one drug at the same time. In this study, patients are treated with the already marketed drug paclitaxel (administered every 3 weeks by infusion)and with the investigational drug CHR-2797 (given orally, once daily). The purpose of this study is to evaluate if it is safe to administer these two drugs together, and how well the combination is tolerated by patients. The first patients will receive a 90mg dose of CHR-2797; doses will be increased in subsequent patients, as long as they are adequately tolerated.