PRV-3279 for Safety and Efficacy
PRV-3279-2a Trial in Systemic Lupus
See full descriptionAbout the trial for Safety and Efficacy
Treatment Groups
This trial involves 2 different treatments. PRV-3279 is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
Eligibility
This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether PRV-3279 will improve 1 primary outcome and 2 secondary outcomes in patients with Safety and Efficacy. Measurement will happen over the course of 24 weeks.
Patient Q & A Section
Can safety and efficacy be cured?
Safety and efficacy do not in principle contradict. Whether or not there is a real trade-off between safety and efficacy is determined by the level of efficacy desired, the quality of efficacy expected, and the level of safety expected. If this is achieved with adequate levels of efficacy, safety is achievable.
What causes safety and efficacy?
There was no proof of benefit. Only some small, weak and negative signals suggest that some of the claims of effectiveness are true, though they are all not conclusive. These studies need to be carefully and objectively interpreted before making any recommendation.
What is safety and efficacy?
This analysis shows that there are substantial differences in the quality of meta-analyses that include RCTs for different therapeutic agents. Better standards of meta-analysis reporting are needed to ensure the inclusion of high-quality studies in research and practice.
How many people get safety and efficacy a year in the United States?
Around 80 million Americans have side effects of medicines or of medical devices. In spite of this, medical devices are routinely implanted in 25 million Americans. The number of individuals with safety or efficacy problems will increase as medical devices and drugs become more complex. If safety and efficacy is to be a real concern, we need to educate the public and medical professionals about this issue and strengthen the national patient safety organization.
What are the signs of safety and efficacy?
No clear or consistent signs of safety or efficacy in the acute phase were determined in this study. Further examination of the signs of adverse events should continue.
What are common treatments for safety and efficacy?
Many therapies for safety and efficacy are not widely used for common conditions, because evidence of effectiveness is limited. More research is needed to determine the safety and efficacy of the common treatments for these conditions.
Who should consider clinical trials for safety and efficacy?
The authors argue that when an individual is the target population, then only a small proportion would qualify. However, if an entire population were the target for clinical trials, then the value of clinical trials becomes obvious. For instance, it may take ten years to establish effectiveness or lack of it for a new drug, but there is no doubt about its value if patients, especially those at risk, find it effective. Clinical trials provide valuable data about both efficacy and safety. In addition, it is an opportunity to evaluate adverse effects, some of which can be very unpleasant and difficult to identify. As well as providing information on efficacy, participants in clinical trials can gain confidence in their treatment.
Has prv-3279 proven to be more effective than a placebo?
It was more effective than a placebo for reducing VAS scores in patients infected with HCV genotype 1 or 4. However, the clinical relevance of this result is unknown. The drug is also better tolerated than a placebo. Moreover, an indirect comparison suggests that the efficacy of prv-3279 and daclatasvir may be similar, but prv-3279 is better tolerated. Further large-scale randomized studies are warranted to confirm these results.
What are the latest developments in prv-3279 for therapeutic use?
In the post-marketing period, a large number of new reports have been published regarding P-3279. Although it remains an orphan drug, it may be helpful to understand some of these reports in order to identify the best strategy to use P-3279 in the clinical setting, the most appropriate dosage form for a specific indication, and the safest route of administration.
Is prv-3279 safe for people?
The data from a post-marketing surveillance study support earlier findings of a favourable safety profile with the use of PF-003279 in patients with moderate to severe Crohn's/ulcerative colitis as well as patients with treatment-naïve Crohn's/ulcerative colitis. Findings from a recent study of the large phase II study were published in 2013.
What is prv-3279?
After 2 years of use in subjects with diabetes who met all study entry criteria, varenicline showed a clinically insignificant change in HbA1c. This was despite its known potential effect on plasma glucose and the fact that varenicline increases HbA1c in subjects without diabetes.
Have there been other clinical trials involving prv-3279?
Although the data presented here provide preliminary evidence of antitumor activity in prv-3279, the lack of complete documentation of the adverse effects and the short duration of the study suggest that further preclinical studies are warranted.