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NotablePrimary completion date: Oct 2017 to Oct 2020
Study completion date: Jun 2019 to Jun 2022
v12
StoppedTrial status: Recruiting to SuspendedSponsor's reason: Funds from original NIH grant, AT4332, have been exhausted.
While new funding is thought with revised study design, no new patients will be…
Primary completion date: Mar 2014 to Oct 2017
Study sites: 2 to 1
Study completion date: Jun 2014 to Jun 2019
v11
NotablePrimary completion date: Oct 2011 to Mar 2014v10Show 8 more changesShow less
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Systemic lupus erythematosus (SLE) is a chronic inflammatory disease which often has debilitating and potentially life-threatening consequences. The cause of SLE is unknown and current therapies lack specificity and carry significant side-effects. We previously discovered the depletion of glutathione in lymphocytes of patients with SLE and associated this metabolic change with the elevation of the mitochondrial transmembrane potential.
This study will titrate to tolerance during an initial 3 month open label period and then subjects will be randomized to one of 2 arms.
It was determined by statistical analysis that each group must have 105 subjects. All subjects will be enrolled and evaluated for tolerance of NAC between dosages of 2.4 g/day and 4.8 g/day for 3 months. After A 3-month open-label dose-titration phase, SLE subjects will be randomized into 2 groups of 105 subjects either to continue the tolerated dosage of NAC or switched to equal number of placebo capsules. There will be up to seven study visits per SLE subject, including the screening and wash out visits. Visits 2-6 will be scheduled three months apart. The study will last 13 months with the wash-out visit. Each subject will donate approximately 100 ml of blood for biomarker studies at each visit. Healthy control subjects will donate blood at the same time. They will be matched to the SLE subjects by gender, age within 10 years, and ethnicity. Their blood will be used as reference for biomarker assays.
There is a consent form required to participate in the phase II study.
Trial Details
NCT Number
NCT00775476
Lead Sponsor
State University of New York - Upstate Medical University Collaborators: Cedars-Sinai Medical Center, Penn State University, Columbia University, Hospital for Special Surgery, New York, Yale University, Ohio State University, Oklahoma City VA Health Care System, St. Luke's Hospital and Health Network, Pennsylvania, Emory University, University of Pittsburgh, University of Kentucky, University of Rochester