MW189 for Cerebral Hemorrhage

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Johns Hopkins Hospital, Baltimore, MD
Cerebral Hemorrhage+1 More
MW189 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called MW189 is safe and tolerable in people with ICH.

See full description

Eligible Conditions

  • Cerebral Hemorrhage

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether MW189 will improve 1 primary outcome in patients with Cerebral Hemorrhage. Measurement will happen over the course of 7 days post-randomization.

7 days post-randomization
Difference in the proportion of all cause-morality between arms

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Experimental
1 of 2
Control
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. MW189 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental
Drug
MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
Control
Other
Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 7 days post-randomization
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 7 days post-randomization for reporting.

Closest Location

Johns Hopkins Hospital - Baltimore, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Confirmed diagnosis of spontaneous, non-traumatic ICH.
10 mL ≤ ICH ≤ 60 mL (confirmed via diagnostic and stability CT scans utilizing volumetric assessment)
Participants receiving anticoagulants are eligible upon reversal and stability within 24hrs after onset of ICH symptoms
Age ≥ 18 years
Able to receive first dose of test article ≤ 24h after onset of ICH symptoms
NIHSS score ≥ 2 at randomization or Glasgow Coma Scale ≥ 5 at randomization
Controlled blood pressure (systolic BP < 180 mm Hg) at randomization.
Premorbid magnetic resonance spectroscopy (mRS) of 0-2
Has adequate venous access
No planned surgical intervention except EVD

Patient Q&A Section

What are the signs of hemorrhage?

"Signs of hemorrhage frequently include pain at the site of bleeding, pale and slow skin, red, oozing blood, and rapid deterioration of breathing and blood pressure. Pain at the site of bleeding may be described as sharp or dull, while skin pale and sluggish has little value in distinguishing between shock and shock from bleeding." - Anonymous Online Contributor

Unverified Answer

Can hemorrhage be cured?

"Hemorrhage may not be a'sickness' that can be cured. Anesthesiologists often see patients with hematemesis after spinal or general anesthetic who then recover within hours, or may continue to show symptoms of hemorrhage for the rest of their life. We need to learn about the pathogenesis and treatment of this seemingly'sickness'. It is not'sickness' that can be cured, but the illness that causes it." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hemorrhage?

"Treatment for hemorrhage depends on a variety of factors. More than half a million hemorrhages are hospitalized in the United States each year. Treating the patient is the primary focus; however, the care of the provider is also important. If patients with major bleeding are not treated within six hours, they can be fatal. Anticoagulation is the only effective therapy for chronic thromboembolic pulmonary arterial hypertension." - Anonymous Online Contributor

Unverified Answer

What causes hemorrhage?

"The risk of hemorrhage occurring after head and neck cancer treatment and for smokers may be due to the development of vascular malformations, which can develop through radiotherapy or systemic therapy." - Anonymous Online Contributor

Unverified Answer

How many people get hemorrhage a year in the United States?

"Each year over 250,000 Americans are harmed by hemorrhage. Hemorrhage is a leading cause of morbidity and early death in the United States. Patients with hemorrhage have a mean length of stay in a hospital of about 21 days, and are at high risk for readmission and adverse events. Hemophilia B is the most common cause of hemorrhagic disease." - Anonymous Online Contributor

Unverified Answer

What is hemorrhage?

"Hemorrhage is blood loss from a vessel or organ. During the process of childbirth, the placenta provides nourishment so that women can give birth after giving birth. In the fetus, fetal hemorrhage is a normal process, which allows for the formation of blood cells. When there is maternal hemorrhage, a part of the blood is normally shed and it has to be replaced by the mother. Blood can be shed because of childbirth or after childbirth. It is a normal process not a problem. Hemorrhaging can cause complications such as low blood pressure. One can experience shock and collapse." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hemorrhage?

"Based on the published data and the evidence in the current literature, we conclude that patients who may benefit from clinical trials include those with an unstable hemodynamic status (such as those with coagulopathy, massive fluid overload, poor cardiac function, shock, and sepsis) or those for whom alternative therapeutic options are not currently available." - Anonymous Online Contributor

Unverified Answer

Has mw189 proven to be more effective than a placebo?

"With more than half of patients satisfied to continue to use Mw189 for 2 years, Mw189 may have been shown to be more effective and well accepted than a placebo as regards symptoms and quality of life." - Anonymous Online Contributor

Unverified Answer

Does hemorrhage run in families?

"Heterozygosity of both the E4 and FH2 alleles appears to be related to an increased tendency toward hemorrhagic complications in the course of PE. No interactions with the A45G and N402Y alleles were observed." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of hemorrhage?

"Hemorrhage is a complex array of causes that must be considered when an emergency room physician is treating a patient admitted to the hospital with symptoms of a potential bleed. Most patients with a suspected acute hemorrhage will require a detailed history of what caused their bleed as well as examination for bleeding risk factors. The likelihood of identifying a primary cause of an acute bleed in an elderly patient depends on the clinical setting for the specific problem. In this article, hemorrhage is described in relation to the location (i.e., the blood vessel from which the bleed will come), the cause (i.e., what the blood vessels contained), and the mechanism (how the vessel was obstructed) of a suspected acute hemorrhage." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hemorrhage?

"If someone receives a traumatic hemorrhagic injury it is most likely a young person. Most non-traumatic hemorrhagic injuries occur in the middle-aged or elderly. In addition with increasing survivorship in children trauma, the elderly continue to be the largest group of trauma patients. The average age of a patient who suffers a traumatic hemorrhagic injury is around 20 years. This is different compared to non-traumatic hemorrhagic injuries, where the average age is roughly around 50. To provide care to the young and old injured people, trauma centers around the world have changed the ways they manage trauma care. Trauma center trauma surgeons have started treating victims of penetrating and blunt injuries through the use of Advanced Trauma Life Support (ATLS)." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in mw189 for therapeutic use?

"This is the 5th generation of recombinant proteins derived from the mw189 gene. The current studies have confirmed, that mw189-DDAV1 may be an effective therapeutic therapy for acute hemorrhagic infarct in human." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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